Predicate Devices

K161689, K063861, K120847, K161689, K150295, K080594

Reference Devices

K160670, K160519, K150295, K140507, K132067, K120847

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a dental abutment system and its components, focusing on materials, dimensions, and compatibility with CAD/CAM systems for manufacturing. There is no mention of AI or ML in the intended use, device description, or performance studies. The reference to "CEREC AI" in the intended use section refers to a specific model of the Sirona CEREC scanning system, not artificial intelligence technology within the abutment itself.

Therapeutic

No
The device provides support for prosthetic restorations, which is a structural function rather than a therapeutic one (i.e., treating or curing a disease).

Diagnostic

No

Explanation: The Osstem Abutment System is described as providing support for prosthetic restorations such as crowns, bridges, or overdentures in conjunction with dental implants. Its function is to hold these prosthetics, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description explicitly lists numerous physical components made of materials like titanium alloy, indicating it is a hardware device, not software-only. While it mentions digital design and manufacturing using software, the core device is a physical abutment system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the Osstem Abutment System is for providing support for prosthetic restorations (crowns, bridges, overdentures) with a dental implant. This is a mechanical function within the body, not a diagnostic test performed on samples taken from the body.
Device Description: The description reinforces the mechanical support function and lists components that are physical parts for dental restorations.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
Anatomical Site: The device is used in the mandible or maxilla, which are anatomical locations for dental implants, not sites for collecting diagnostic samples.
Intended User/Care Setting: The mention of dental laboratories for manufacturing/milling further indicates a focus on creating physical dental prosthetics.
Performance Studies: The performance studies focus on biocompatibility, sterilization, and mechanical properties (fatigue, retention), which are relevant to the physical function and safety of an implant component, not diagnostic accuracy.

In summary, the Osstem Abutment System is a medical device used in dentistry for supporting prosthetic restorations, not a device used for performing diagnostic tests on in vitro samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

· Link Abutment for CEREC
The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.

Product codes (comma separated list FDA assigned to the subject device)

NHA

Device Description

Osstem Abutment System is compatible with the following implant systems.
Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
Osstem Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
Osstem Abutment System is substantially equivalent in design, function and intended use to the predicate devices as above.

Device Content:
Transfer Abutment: Used for prosthetic restoration, general cement-type prosthesis. Material: Titanium Alloy (Ti-6Al-4V, ASTM F136). Diameter: 4.0, 4.6, 5.0, 6.0, 7.0 mm. Post Height: 4.0, 5.5, 7.0 mm.
Angled Abutment: Used for prosthetic restoration, general cement-type prosthesis when path adjustment is necessary. Material: Titanium Alloy (Ti-6Al-4V, ASTM F136). Diameter: 4.0, 4.5, 5.0, 6.0 mm. Post Height: 8 mm. Angulation: 17°.
Link Abutment for Cerec: Used for customized prosthetic restoration. Indicated for screw-retained single tooth or cement-retained single tooth and bridges restorations. Compatible with Sirona CEREC MC X and MC XL prosthetic milling system. Material: Titanium Alloy (Ti-6Al-4V, ASTM F136). Diameter: 4.5 mm. Post Height: 4.7 mm.
Temporary Abutment: Used for temporary prosthetic restoration to maintain esthetic appearance until final prosthesis is made. Material: Titanium Gr.3 (ASTM F67). Diameter: 4.0, 4.5 mm. G/H: 1.0, 3.0 mm.
Multi Angled Abutment: Used to adjust prosthesis path when fixtures are implanted in mandibular bone for full denture. Material: Titanium Alloy (Ti-6Al-4V, ASTM F136). Diameter: 4.9 mm. Height: 5, 5.1, 5.5, 5.6, 6, 6.1, 6.5, 6.6, 7.5, 7.6 mm. Angulation: 17°, 30°.
Multi NP-Cast Cylinder: Used for prosthetic restoration, screw-retained type prosthesis by casting with non-precious metal alloy, with Multi Abutment. Creates framework of final prosthesis. Material: Co-Cr-Mo Alloy (Cylinder Body) + POM (Cylinder Sleeve). Diameter: 5.0 mm. Length: 7.3 mm.
Multi Combination Cylinder: Used for prosthetic restoration, combination-retained type prosthesis with Multi Abutment. Material: Titanium Gr. 3 (ASTM F67). Diameter: 5.0 mm. Length: 7.3 mm.
Convertible Angled Cylinder: Used for prosthetic restoration, combination-retained type prosthesis with Convertible Abutment when path adjustment is necessary at 17° axial angle. Material: Titanium Gr. 3 (ASTM F67). Diameter: 4.2, 5.0, 6.3 mm. Length: 7.8 mm. Angulation: 17°.
Stud Abutment: Used for prosthetic restoration, stud type overdenture prosthetics. Material: Titanium Alloy (Ti-6Al-4V, ASTM F136). Diameter: 3.5 mm. Head length: 2.5 mm.
O-ring: Inserted into retainer or retainer cap, serves as a buffer for abutments/implants and denture fixation. Material: NBR (Acrylonitrile & Butadiene Polymer). Diameter: 3.5 mm.
O-ring Retainer Cap: Used for stud-type overdenture. Inserted and fixed into denture, connected with abutment/implants. Material: Titanium Gr. 3 (ASTM F67). Diameter: 3.95 mm. Height: 2.9 mm.
Port Abutment: Used for prosthetic restoration, implant retained overdenture at maxilla/mandible for edentulous patients. Material: Titanium Alloy (Ti-6Al-4V, ASTM F136). Diameter: 3.5, 3.7, 4.1, 4.8, 5.1 mm. G/H: 1, 2, 3, 4, 5, 6, 7 mm.
Port Angled Abutment: Used for prosthetic restoration, implant retained overdenture needing path compensation at maxilla/mandible for edentulous patients. Material: Titanium Alloy (Ti-6Al-4V, ASTM F136). Diameter: 4.63, 4.66, 4.68, 4.72, 4.73, 4.74, 4.77, 4.82 mm. Height: 6.5, 6.8, 7.5, 7.6 mm. Angulation: 10°, 17°, 30°.
Port Angled Abutment Head: Part used to connect with Port Angled Abutment for prosthetic restoration. Material: Titanium Alloy (Ti-6Al-4V, ASTM F136). Diameter: 4.6 mm. Height: 3.7 mm.
Port Male, Port Extended Male: Used for prosthetic restoration. Inserted between Port Abutment/Port Angled Abutment and Port Male Cap to maintain retention of overdenture. Material: Nylon. Diameter: 4.75 mm. Height: 1.8 mm.
Port Male Cap: Used for prosthetic restoration. Fixes Port Male or Port Extended Male by insertion into the denture. Material: Titanium Alloy (Ti-6Al-4V, ASTM F136). Diameter: 5.5 mm. Height: 2.25 mm.
Port Male Kit: Provides accessories for use with Port Abutment or Port Angled Abutment. Includes Port Male Cap, Port Provisional Male, Port Spacer, and 3 different types of Port Male as a set. Set Configuration: Port Male Cap + Port Provisional Male + Port Spacer + Port Male (3ea).
Abutment Screw: Connects an abutment to the fixture. Material: Titanium Alloy (Ti-6Al-4V, ASTM F136). Diameter: 2, 2.05 mm. Length: 7.5, 9.6 mm.
Cylinder Screw: Connects a cylinder to the abutment. Material: Titanium Alloy (Ti-6Al-4V, ASTM F136). Diameter: 2.2, 2.5 mm. Length: 4.35, 4.9 mm.
Esthetic-low Temporary Cylinder: Used for prosthetic restoration (temporary prosthesis before final prosthesis). Connects with Multi Abutment, US Multi Angled Abutment or Esthetic-low Abutment for overdenture and bridge cases. Material: Titanium Gr. 3 (ASTM F67). Diameter: 4.8, 5.5 mm. Length: 12 mm.
Temporary Cap (Narrow Ridge): Used for temporary prosthetic restoration to protect upper structure while final prosthesis is made. Material: PC (Poly Carbonate). Diameter: 4 mm. Length: 9.6 mm.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI

Input Imaging Modality

Not Found

Anatomical Site

dental implant (mandibles and maxillae)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental laboratories

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence.

Biocompatibility Evaluation: Biocompatibility testing was performed following the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"and the ISO 10993 suite of standards.
Sterilization Validation: Subject devices are provided to the market in non-sterile status, and steam sterilization validation was considered according to ISO 17665-1.
Mechanical Properties: Fatigue testing was considered according to the FDA Guidance Document Guidance for Industry and FDA Staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment and ISO 14801 standard with the worst case scenario. Retention testing for dental attachments was conducted.
No clinical studies are submitted.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K161689, K063861, K120847, K161689, K150295, K080594

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K160670, K160519, K150295, K140507, K132067, K120847

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

July 12, 2019

Osstem Implant Co., Ltd. % Peter Lee QA/RA Manager Hiossen Inc. 85 Ben Fairless Dr. Fairless Hills, Pennsylvania 19030

Re: K182091

Trade/Device Name: Osstem Abutment System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: June 12, 2019 Received: June 13, 2019

Dear Peter Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for

Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

Image /page/2/Picture/0 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo includes the company name in bold, black font, with the word "OSSTEM" also appearing in orange next to the company name. The contact information includes the company's address, telephone number (+82 51 850 2500), fax number (+82 51 861 4693), and website (www.osstem.com).

510(k) Number: K182091

Device Name: Osstem Abutment System

Indication for Use:

Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

· Link Abutment for CEREC

The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.

X Prescription Use (21 CFR 801 Subpart D) Over-The Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

3

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

510(k) Summary

K182091

Date: July 12, 2019

1. Administrative Information

Submitter	OSSTEM IMPLANT Co., Ltd.
- Address	66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, 612-070, Korea
- Contact	Ms. Jungmin Yoo
- Phone	+82-51-850-2575
Correspondent	HIOSSEN Inc.
- Address	85 Ben Fairless Dr. Fairless Hills, PA 19030
- Contact	Mr. Peter Lee
- Phone	267-759-7031

2. Device Name and Classification

Trade or (Propreitary) Name	Osstem Abutment System
Common or Usual Name	Dental Abutment
Classification Name	Endosseous dental implant abutment
Regulation Number	21 CFR 872.3630
Device Classification	Class II
Product Code	NHA

3. Predicate Device

Primary Predicate
K161689	OSSTEM Implant System - Abutment, Osstem Implant Co., Ltd.
Reference Predicates
K160670	ET US SS Prosthetic System
K160519	Link Abutment for CEREC, Osstem Implant Co., Ltd.
K150295	LOCATOR RTx, Zest Anchors, Inc.
K140507	Hiossen Prosthetic System, Osstem Implant Co., Ltd.
K132067	Multi Angled Abutment System, Osstem Implant Co., Ltd.
K120847	ET/SS Implant System, Osstem Implant Co., Ltd.
K080594	MS System (Narrow Ridge), Osstem Implant Co., Ltd.
K063861	GS System, Osstem Implant Co., Ltd.
K062030	US System, Osstem Implant Co., Ltd.

4

4. Indication for Use

Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

· Link Abutment for CEREC

The Link Abutment for CEREC is titanium alloy abutments placed onto OSSTEM dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.

5. Device Description

Manufacturer	Model Name	Connection	Diameter (mm)
Osstem Implant Co., Ltd.	TS SA Fixture	Internal Hex	3.2, 3.5, 3.75, 3.77, 4.2, 4.25, 4.4, 4.6, 4.63,
4.65, 4.8, 4.9, 5.05, 5.08, 5.1, 5.25, 5.92, 5.95,
6, 6.2, 6.8, 7.1
	SS SA Fixture	Internal Octa	3.75, 4.1, 4.25, 4.45, 4.6, 4.9, 5, 5.05, 5.92,
5.95, 5.96, 6, 6.8, 6.93
	US SA Fixture	External Hex	3.6, 4.2, 5.1, 5.2
	MS SA Implant	Narrow Ridge	2.5, 2.9

Osstem Abutment System is compatible with the following implant systems.

Osstem Abutment System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Osstem Abutment System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.

Osstem Abutment System is substantially equivalent in design, function and intended use to the predicate devices as above.

Device	Content
Transfer Abutment	Description Transfer Abutment is used for prosthetic restoration. It
		is used for making general cement-type prosthesis.
	Material	Titanium Alloy (Ti-6Al-4V, ASTM F136)
	Diameter (mm)	4.0, 4.6, 5.0, 6.0, 7.0
	Post Height (mm)	4.0, 5.5, 7.0
	Description	Angled Abutment is used for prosthetic restoration. It is used for making general cement-type prosthesis. It is used when a prosthetic's path adjustment is necessary
Angled Abutment	Material	Titanium Alloy (Ti-6Al-4V, ASTM F136)
	Diameter (mm)	4.0, 4.5, 5.0, 6.0
	Post Height (mm)	8
	Angulation	17°
Link Abutment for Cerec	Description	Link Abutment for Cerec is used for customized prosthetic restoration. It is indicated for screw-retained single tooth or cement-retained single tooth and bridges restorations. It is compatible with the Sirona CEREC MC X and MC XL prosthetic milling system.
	Material	Titanium Alloy (Ti-6Al-4V, ASTM F136)
	Diameter (mm)	4.5
	Post Height (mm)	4.7
Temporary Abutment	Description	Temporary Abutment is used for prosthetic restoration. It is used temporarily to maintain esthetic appearance until final prosthesis is made.
	Material	Titanium Gr.3 (ASTM F67)
	Diameter (mm)	4.0, 4.5
	G/H (mm)	1.0, 3.0
Multi Angled Abutment	Description	If a few numbers of fixtures were implanted in mandibular bone for making full denture, some of fixture path should be leaned. Multi Angled Abutment is used to adjust path of prosthesis.
	Material	Titanium Alloy (Ti-6Al-4V, ASTM F136)
	Diameter (mm)	4.9
	Height (mm)	5, 5.1, 5.5, 5.6, 6, 6.1, 6.5, 6.6, 7.5, 7.6
	Angulation	17°, 30°
Multi NP-Cast Cylinder	Description	Multi NP-Cast Cylinder is used for prosthetic restoration. It is used for making screw-retained type prosthesis by casting with non-precious metal alloy; and used with Multi Abutment together. It creates framework of the final prosthesis to be fixed on top of the abutment.
	Material	Co-Cr-Mo Alloy (Cylinder Body) + POM (Cylinder Sleeve)
	Diameter (mm)	5.0
	Length (mm)	7.3
Multi Combination Cylinder	Description	Multi Combination Cylinder is used for prosthetic restoration. It is used for making combination-retained type prosthesis with using Multi Abutment together. It
		tope of the abutment.
	Material	Titanium Gr. 3 (ASTM F67)
	Diameter (mm)	5.0
	Length (mm)	7.3
Convertible Angled Cylinder	Description	Convertible Angled Cylinder is used for prosthetic
restoration. It is used for making combination-retaiend
type prosthesis by using with Convertible Abutment
together. It is used when path adjustment is necessary
at 17° axial angle.
	Material	Titanium Gr. 3 (ASTM F67)
	Diameter (mm)	4.2, 5.0, 6.3
	Length (mm)	7.8
	Angulation	17°
	Description	Stud Abutment is used for prosthetic restoration. It is
used for making stud type overdenture prosthetics.
Stud Abutment	Material	Titanium Alloy (Ti-6Al-4V, ASTM F136)
	Diameter (mm)	3.5
	Head length (mm)	2.5
O-ring	Description	O-ring is inserted into retainer or retainer cap and
serves as a buffer for abutments/implants and denture
fixation.
	Material	NBR (Acrylonitrile & Butadiene Polymer)
	Diameter (mm)	3.5
	Description	O-ring Retainer Cap is used for making stud-type
overdenture. It is inserted and fixed into denture; and is
connected with abutment/implants.
O-ring Retainer Cap	Material	Titanium Gr. 3 (ASTM F67)
	Diameter (mm)	3.95
	Height (mm)	2.9
	Description	Port Abutment is used for prosthetic restoration. It is
for implant retained overdenture at maxilla/mandible in
case of the patient has no teeth.
Port Abutment	Material	Titanium Alloy (Ti-6Al-4V, ASTM F136)
	Diameter (mm)	3.5, 3.7, 4.1, 4.8, 5.1
	G/H (mm)	1, 2, 3, 4, 5, 6, 7
	Description	Port Angled Abutment is used for prosthetic
restoration. It is for implant retained overdenture
needed of path compensation at maxilla/mandible in
case of the patient has no teeth.
Port Angled Abutment	Material	Titanium Alloy (Ti-6Al-4V, ASTM F136)
	Diameter (mm)	4.63, 4.66, 4.68, 4.72, 4.73, 4.74, 4.77, 4.82
	Height (mm)	6.5, 6.8, 7.5, 7.6
	Angulation	10°, 17°, 30°
Port Angled Abutment Head	Description	Port Angled Abutment Head is used for prosthetic
restoration. It is a part that is used to connect with Port
Angled Abutment.
	Material	Titanium Alloy (Ti-6Al-4V, ASTM F136)
	Diameter (mm)	4.6
	Height (mm)	3.7
Port Male, Port Extended Male	Description	Port Male and Port Extended Male is used for
prosthetic restoration. It is used to be inserted between
Port Abutment/Port Angled Abutment and Port Male
Cap and takes a role to maintain retention of
overdenture.
	Material	Nylon
	Diameter (mm)	4.75
	Height (mm)	1.8
Port Male Cap	Description	Port Male Cap is used for prosthetic restoration. It is
used to fix Port Male or Port Extended Male by
inserted into the denture.
	Material	Titanium Alloy (Ti-6Al-4V, ASTM F136)
	Diameter (mm)	5.5
	Height (mm)	2.25
Port Male Kit	Description	Port Male Kit is used for prosthetic restoration by
providing accessories that are used with Port Abutment
or Port Angled Abutment, and it is included of Port
Male Cap, Port Provisional Male, Port Spacer, and 3
different types of Port Male as a set.
	Set Configuration	Port Male Cap + Port Provisional Male + Port Spacer +
Port Male (3ea)
Abutment Screw	Description	Abutment Screw is used to connect an abutment to the
fixture.
	Material	Titanium Alloy (Ti-6Al-4V, ASTM F136)
	Diameter (mm)	2, 2.05
	Length (mm)	7.5, 9.6
Cylinder Screw	Description	Cylinder Screw is used to connect a cylinder to the
abutment.
	Material	Titanium Alloy (Ti-6Al-4V, ASTM F136)
	Diameter (mm)	2.2, 2.5
	Length (mm)	4.35, 4.9
Esthetic-low Temporary Cylinder	Description	Esthetic-low Temporary Cylinder is used for prosthetic
restoration. It is used for making temporary prosthesis
before loading final prosthesis. It is used by connected
with Multi Abutment, US Multi Angled Abutment or
Esthetic-low Abutment to make overdenture and bridge
as multiple cases.
	Material	Titanium Gr. 3 (ASTM F67)
	Diameter (mm)	4.8, 5.5
	Length (mm)	12
Temporary Cap (Narrow Ridge)	Description	Temporary Cap is used for prosthetic restoration
temporarily. It is a component used to protect upper
structure while final prosthesis is made.
	Material	PC (Poly Carbonate)
Diameter (mm)	4
Length (mm)	9.6

5

Image /page/5/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the superscript "6" next to it. Below the word "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.

6

Image /page/6/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the superscript symbol for a registered trademark next to the "M". Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.

7

Image /page/7/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small superscript "6" next to the "M". Below "OSSTEM", the word "IMPLANT" is written in gray. The logo is simple and modern.

8

Image /page/8/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small superscript "6" next to it. Below the word "OSSTEM", the word "IMPLANT" is written in gray. The logo is simple and modern.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

6. Substantial Equivalence Discussion

These subject devices are cleared in past 510(k) submissions but submitted to change their identifiers without modifications of dimensions or shape.

Link Abutment for Cerec, K160519 Multi Angled Abutment, K132067 Abutment Screw, K132067

The Indications for Use Statements are compared in the tables below. It can be seen that the Indications for Use Statements of the Subject and Primary Predicate devices are identical, with the exception of the addition to the Subject Indications for Use Statements language regarding the Link Abutment for CEREC. This language is identical to the Indications for Use Statement of the Reference Device being used for the Substantial Equivalence comparison for the Link Abutment for CEREC. All other reference devices have minor changes in wording, but nothing that affects the intended use or safety and effectiveness of the subject device system.

| | Osstem Abutment System | OSSTEM Implant System -
Abutment | Link Abutment for CEREC |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | Proposed | Predicated (K161689) | Referenced (K160519) |
| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. |
| Indications for
Use Statement | Osstem Abutment System is
intended for use with a dental
implant to provide support
for prosthetic restorations
such as crowns, bridges, or
overdentures.
• Link Abutment for CEREC
The Link Abutment for
CEREC is titanium alloy
abutments placed onto
OSSTEM dental implants to
provide support for
customized prosthetic
restorations. Link Abutment
for CEREC is indicated for
screw-retained single tooth or
cement-retained single tooth
and bridge restorations. All
digitally designed copings
and/or crowns for use with
the Link abutment for
CEREC is to be scanned | The OSSTEM Implant
System - Abutment is
intended for use with a dental
implant to provide support
for prosthetic restorations
such as crowns, bridges, or
overdentures. | The Link Abutment for
CEREC is titanium alloy
abutments placed onto
HIOSSEN dental implants to
provide support for
customized prosthetic
restorations. Link Abutment
for CEREC is indicated for
screw-retained single tooth or
cement-retained single tooth
and bridge restorations. All
digitally designed copings
and/or crowns for use with
the Link abutment for
CEREC is to be scanned
using Sirona CEREC AC or
CEREC AF or CEREC AI,
designed using Sirona inLab
software (Version 3.65) or
Sirona CEREC Software
(Version 4.2) and
manufactured using a Sirona
CEREC or inLab MC X or |

9

Image /page/9/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. There is a small superscript "6" next to the "M" in "OSSTEM."

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

| using Sirona CEREC AC or
CEREC AF or CEREC AI,
designed using Sirona inLab
software (Version 3.65) or
Sirona CEREC Software
(Version 4.2) and
manufactured using a Sirona
CEREC or inLab MC X or
MC XL milling unit.
CAD/CAM
manufacturing/milling occurs
at dental laboratories per the
design limitations of the
Sirona CEREC. | MC XL milling unit.
CAD/CAM
manufacturing/milling occurs
at dental laboratories per the
design limitations of the
Sirona CEREC. |

-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------

Except for them, the subject devices are substantially equivalent in indications and design principles to the predicate devices as shown below.

	Transfer Abutment	Transfer Abutment	Remark
510(k) No.	Proposed	Predicated (K161689)	-
Manufacturer	Osstem Implant Co., Ltd.	Osstem Implant Co., Ltd.	Identical
Design	Image: Transfer Abutment	Image: Transfer Abutment	Identical
Indications for Use
Statement	The Osstem Abutment System
is intended for use with a
dental implant to provide
support for prosthetic
restorations such as crowns,
bridges, or overdentures.	The OSSTEM Implant System

Abutment is intended for use
with a dental implant to
provide support for prosthetic
restorations such as crowns,
bridges, or overdentures. | Identical |
| Principle of
Operation | Using making for general
cement-type prosthesis. | Using making for general
cement-type prosthesis. | Identical |
| Material | Titanium Alloy
(Ti-6Al-4V, ASTM F136) | Titanium Alloy
(Ti-6Al-4V, ASTM F136) | Identical |

10

Image /page/10/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The logo is simple and modern.

	D(Ø)	G/H	Post	D(Ø)	G/H
Dimension (mm)	4	1, 2, 3, 4,
5, 6, 7	5.5, 7				-. Addition of Ø4
(New, smallest
diameter)
	4.6	6, 7	5.5, 7	4.6	1, 2, 3, 4,
5	5.5, 7	-. Addition of Ø4.6
(G/H 6, 7mm)
	5	6, 7	4, 5.5,
7		5	1, 2, 3, 4,
5	4, 5.5,
7	-. Addition of Ø5
(G/H 6, 7mm)
	6	6, 7	4, 5.5,
7		6	1, 2, 3, 4,
5	4, 5.5,
7	-. Addition of Ø6
(G/H 6, 7mm)
	7	1, 2, 3, 4,
5, 6, 7	4				-. Addition of Ø7
(Post 4mm)
	7	6, 7	5.5	7	1, 2, 3, 4,
5	5.5	-. Addition of Ø7
(G/H 6, 7mm)
S.E.	Similarities
Proposed Transfer Abutment has same design, function and indications for use
statement; and is made with same material with same manufacturing method by same
manufacturer and is generally used for cement-retained restoration compared to that of
the predicated Transfer Abutment (K161689).
Differences
The proposed Transfer Abutment has diameter of 4.0 to 7.0mm that has smallest
diameter among the proposed and the predicated Transfer Abutment (K161689).
However, the proposed abutment is straight type; therefore, we do not consider
additional fatigue testing.
.. Except for its size of diameter, proposed Transfer Abutment and the predicated
Transfer Abutment have common in design, function, indication for use, material,
manufacturing process, manufacturer, etc.; therefore, the proposed Transfer Abutment is
substantially equivalent to the predicated Transfer Abutment (K161689).

	Angled Abutment	Angled Abutment	Remark
510(k) No.	Proposed	Predicated (K120847)	-
Manufacturer	Osstem Implant Co., Ltd.	Osstem Implant Co., Ltd.	Identical
Design	Image: Angled abutment with TiN Coating	Image: Angled abutment with TiN Coating	Identical except for
its TiN coating
section
Indications for Use
Statement	The Osstem Abutment System
is intended for use with a	The abutment is intended for
use with a dental implant	Identical

11

Image /page/11/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is in orange, with a small superscript "6" next to it. Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and clean, with a focus on the company name.

| | dental implant to provide
support for prosthetic
restorations such as crowns,
bridges, or overdentures. | fixture to provide support for
prosthetic restorations such as
crowns, bridges, or
overdenture. | |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Principle of
Operation | Using making general cement-
type prosthesis when a
prosthetic's path adjustment is
necessary. | Using making general cement-
type prosthesis when a
prosthetic's path adjustment is
necessary. | Identical |
| Material | Titanium Alloy
(Ti-6Al-4V, ASTM F136) | Titanium Alloy
(Ti-6Al-4V, ASTM F136) | Identical |
| Diameter (mm) | 4.0, 4.5, 5.0, 6.0 | 4.3, 4.5, 5.0, 5.5, 6.0 | Ø4.0 is added; and
the rest is within the
range of the
predicates |
| Post Height (mm) | 8 | 8 | Identical |
| Angulation | 17° | 17° | Identical |
| S.E. | Similarities
Proposed Angled Abutment has same design, function and indications for use statement;
and is made with same material with same manufacturing method by same manufacturer
and is generally used for cement-retained restoration compared to that of the predicated
Angled Abutment (K120847).
Differences
TiN coating section between the proposed and predicated Angled Abutment is different.
The proposed Angled Abutment has diameter of 4.0 to 6.0mm that has smallest diameter
among the proposed and the predicated Angled Abutment (K120847). Therefore, we do
consider the additional fatigue testing.
... While TiN coating section is changed and the devices that has different size of
diameter are added, proposed Angled Abutment and the predicated Angled Abutment
have common in design, function, indications for use, material, manufacturing process,
manufacturer, etc.; therefore, the proposed Angled Abutment is substantially equivalent
to the predicated Angled Abutment (K120847). | | |

	Temporary Abutment	Temporary Abutment	Remark
510(k) No.	Proposed	Predicated (K161689)	-
Manufacturer	Osstem Implant Co., Ltd.	Osstem Implant Co., Ltd.	Identical

12

Image /page/12/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small degree symbol next to the "M". Below the word "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.

| Design | Image: Osstem Abutment System | Image: OSSTEM Implant System - Abutment | Identical except for
its shape of the post |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Indications for Use
Statement | The Osstem Abutment System
is intended for use with a
dental implant to provide
support for prosthetic
restorations such as crowns,
bridges, or overdentures. | The OSSTEM Implant System

Abutment is intended for use
with a dental implant to
provide support for prosthetic
restorations such as crowns,
bridges, or overdentures. | Identical |
| Principle of
Operation | Cement/screw retained
restoration; using making
temporary prosthesis to
maintain aesthetic appearance
until final prosthesis is made. | Cement/screw retained
restoration; using making
temporary prosthesis to
maintain aesthetic appearance
until final prosthesis is made. | Identical |
| Material | Titanium Gr. 3
(ASTM F67) | Titanium Gr. 3
(ASTM F67) | Identical |
| Diameter (mm) | 4.0, 4.5 | 4.0, 4.5 | Identical |
| Post Height (mm) | 10 | 10 | Identical |
| S.E. | Similarities
Proposed Temporary Abutment has same design (except for its shape of post), function
and indications for use statement; and is made with same material with same
manufacturing method by same manufacturer and is used for cement/screw-retained
restoration compared to that of the predicated Temporary Abutment (K161689).

Differences
Shape of the post between the proposed and predicated Temporary Abutment is
different. Since proposed device is used temporarily, we do not consider additional
fatigue testing.

.. While shape of the post of Temporary Abutment is changed compared to the
predicates, proposed Temporary Abutment and the predicated Temporary Abutment
have common in design, function, indications for use, material, manufacturing process,
manufacturer, etc.; therefore, the proposed Temporary Abutment is substantially
equivalent to the predicated Temporary Abutment (K161689). | | |

| | Multi NP-Cast
Cylinder | Esthetic-low
Gold Cylinder | NP-Cast
Abutment | Remark |
|------------|---------------------------|------------------------------------|--------------------------------------|--------|
| 510(k) No. | Proposed | Primary
Predicated
(K140507) | Reference
Predicated
(K140507) | - |

13

Image /page/13/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small superscript "6" next to the "M". Below "OSSTEM", the word "IMPLANT" is written in gray. The logo is simple and modern.

| Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical | | Multi
Combination Cylinder | Convertible
Combination Cylinder | Remark |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Design | Image: Osstem Abutment System | Image: Hiossen Prosthetic system | Image: Hiossen Prosthetic system | Different
but similar | 510(k) No. | Proposed | Predicated (K120847) | - |
| Indications for
Use Statement | The Osstem
Abutment System is
intended for use with
a dental implant to
provide support for
prosthetic
restorations such as
crowns, bridges, or
overdentures. | Hiossen Prosthetic
system is intended for
use with a dental
implant to provide
support for prosthetic
restorations such as
crowns, bridges, or
over-dentures. | Hiossen Prosthetic
system is intended for
use with a dental
implant to provide
support for prosthetic
restorations such as
crowns, bridges, or
over-dentures. | Identical | Manufacturer | Osstem Implant Co., Ltd. | Osstem Implant Co., Ltd. | Identical |
| Principle of
Operation | Using making screw-
retained type
prosthesis by casting
with non-precious
metal alloy; and used
with Multi Abutment
together by creating
framework of the
final prosthesis to be
fixed on top of the
abutment. | Using making screw-
retained type
prosthesis by casting
with gold alloy; and
used with Multi
Abutment or
Esthetic-low
Abutment by creating
framework of the
final prosthesis to be
fixed on top of the
abutment. | Using screw-retained
type prosthesis in
cases with path,
aesthetic, and spatial
constraints by casting
with non-precious
metal alloy. | Similar | Design | | | Similar |
| Material | Body: Co-Cr-Mo Alloy
Sleeve: POM | Body: Gold Alloy
Sleeve: POM | Body: Co-Cr-Mo Alloy
Sleeve: POM | Partial Identical | Indications for Use
Statement | The Osstem Abutment System
is intended for use with a
dental implant to provide
support for prosthetic
restorations such as crowns,
bridges, or overdentures. | The abutment is intended for
use with a dental implant to
provide support for prosthetic
restorations such as crowns,
bridges, or overdenture. | Identical |
| Casting Material | Non-precious
metal alloy | Gold alloy | Non-precious
metal alloy | Different | Principle of
Operation | Using making combination-
retained type prosthesis with
using Multi Abutment together
by creating framework of the
final prosthesis to be fixed on
top of the abutment. | Using making combination-
retained type prosthesis with
using Convertible Abutment
together by creating
framework of the final
prosthesis to be fixed on top
of the abutment. | Identical |
| Diameter (mm) | 5.0 | 4.8 | 4.0, 4.5 | Bigger than the
predicates | Material | Titanium Gr. 3
(ASTM F67) | Titanium Gr. 3
(ASTM F67) | Identical |
| Length (mm) | 7.3 | 10 | 10 | Smaller than the
predicates | Diameter (mm) | 5.0 | 4.2~6.3 | Within the range of
the predicates |
| S.E. | Similarities
Proposed Multi NP-Cast Cylinder has similar design that is composed with body and
sleeve together; function; indications for use statement; and is used for making screw-
retained restoration with Multi Abutment compared to that of the predicated Esthetic-low
Gold Cylinder (K140507).
Differences
Proposed Multi NP-Cast Cylinder has bigger diameter than that of the predicated Esthetic- | | | | Length (mm) | 7.3 | 7 | Different but similar |
| S.E. | Similarities
Proposed Multi Combination Cylinder has similar design, function, and indications for
use statement; and is made with same material with same manufacturing method by
same manufacturer and is used for making combination-retained restoration with Multi
Abutment compared to that of the predicated Convertible Combination Cylinder | | | | | | | |

14

Image /page/14/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a small superscript "6" next to the "M". Below "OSSTEM", the word "IMPLANT" is written in gray, in a smaller font size. The logo is simple and clean, with a focus on the company name.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

low Gold Cylinder and NP-Cast Abutment. Also, proposed Multi NP-Cast Cylinder is being casted with non-precious metal alloy as same as the predicated NP-Cast Abutment, but the predicated Esthetic-low Gold Cylinder is being casted with gold alloy. Since the casting material in used for proposed Multi NP-Cast Cylinder has better or substantially equivalent in mechanical strength than that of the predicates; therefore, we do not consider additional fatigue testing.

: · Proposed Multi NP-Cast Cylinder has similar design that is composed with body and sleeve together; function; and indication for use; compared to that of the predicated Esthetic-low Gold Cylinder (K140507). Therefore, the proposed Multi NP-Cast Cylinder and the predicated Esthetic-low Gold Cylinder is substantially equivalent each other.

15

Image /page/15/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the number "6" as a superscript. Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.

	Differences
	Dimension between the proposed Multi Combination Cylinder and the predicated
Convertible Combination Cylinder is different. However, proposed Multi Combination
Cylinder has diameter that has within the range of the predicates; and it is a straight type
cylinder; so, so we do not consider additional fatigue testing.
	: · Proposed Multi Combination Cylinder has similar design, function, and indication for
use; and is casting with same material to make final prosthesis compared to that of the
predicated Convertible Combination Cylinder (K120847). Therefore, the proposed Multi
Combination Cylinder and the predicated Convertible Combination Cylinder is
substantially equivalent each other.

	Convertible Angled Cylinder	Convertible Angled Cylinder	Remark
510(k) No.	Proposed	Predicated (K063861)	-
Manufacturer	Osstem Implant Co., Ltd.	Osstem Implant Co., Ltd.	Identical
Design	Image: Convertible Angled Cylinder	Image: Convertible Angled Cylinder with gold coating	Identical except for
TiN coating on its
surface
Indications for Use
Statement	The Osstem Abutment System
is intended for use with a
dental implant to provide
support for prosthetic
restorations such as crowns,
bridges, or overdentures.	GS System is indicated for use
in partially or fully edentulous
mandibles and maxillae, in
support of single or multiple-
unit restorations including;
cemented retained, screw
retained, or overdentrue
restorations, and terminal or
intermediate abutment support
for fixed bridgework. GS
System is for one stage
surgical procedures. It is not
intended for immediate load.	The proposed
device and the
predicated device
has different
indication for use in
language, however
the difference in
language does not
change the intended
use or substantial
equivalence status
Principle of
Operation	Using making combination-
retained type prosthesis by
using with Convertible
Abutment together when path
adjustment is necessary.	Using making combination-
retained type prosthesis by
using with Convertible
Abutment together when path
adjustment is necessary.	Identical
Material	Titanium Gr. 3
(ASTM F67)	Titanium Gr. 3
(ASTM F67)	Identical
Surface	Non-TiN coating	TiN coating	Different
Diameter (mm)	4.2, 5.0, 6.3	4.2, 5.0, 6.3	Identical
Length (mm)	7.8	7.8	Identical
Angulation	17°	17°	Identical

16

Image /page/16/Picture/0 description: The image contains the logo for Osstem Implant. The logo is in orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray.

Connection	Hex, Non-Hex, Octa	Hex, Octa	Identical
S.E.	Similarities
Proposed Convertible Angled Cylinder has same design (except for its surface on TiN-
coated), function and indications for use statement; and is made with same material with
same manufacturing method by same manufacturer and is used for making combination-
retained restoration with Convertible Abutment compared to that of the predicated
Convertible Angled Cylinder (K063861).

Differences
Proposed Convertible Angled Cylinder has no TiN coating on its surface while the
predicates have TiN coating on its surface. Also, the proposed Convertible Angled
Cylinder Non-Hex type is added. Since this Non-Hex type addition is made having same
dimensions to the predicates; therefore, we do not consider additional fatigue testing.
... While proposed devices has non-TiN coated on its surface, proposed Convertible
Angled Cylinder and the predicated Convertible Angled Cylinder have common in
design, function, indications for use, material, manufacturing process, manufacturer,
etc.; therefore, the proposed Convertible Angled Cylinder is substantially equivalent to
the predicated Convertible Angled Cylinder (K063861). | | |

	Stud Abutment	Stud Abutment	Remark
510(k) No.	Proposed	Predicated (K161689)	-
Manufacturer	Osstem Implant Co., Ltd.	Osstem Implant Co., Ltd.	Identical
Design	Image: Stud Abutment Design	Image: Stud Abutment Design	Identical
Indications for Use
Statement	The Osstem Abutment System
is intended for use with a
dental implant to provide
support for prosthetic
restorations such as crowns,
bridges, or overdentures.	The OSSTEM Implant System

Abutment is intended for use
with a dental implant to
provide support for prosthetic
restorations such as crowns,
bridges, or overdentures. | Identical |
| Principle of
Operation | Using making stud type
overdenture prosthetics | Using making stud type
overdenture prosthetics | Identical |
| Material | Titanium Alloy
(Ti-6Al-4V, ASTM F136) | Titanium Alloy
(Ti-6Al-4V, ASTM F136) | Identical |
| Surface | Partial TiN coated in upper | Partial TiN coated in upper | Identical |

17

Image /page/17/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray below it. There is a small superscript "6" next to the word "OSSTEM".

	D (Ø)	3.5
Dimension (mm)	Body Length	6, 6.4,
7,7.4,
8, 8.4,
9, 9.4,
10,10.4,
11, 11.4		Body Length	6, 6.4,
7,7.4,
8, 8.4,
9, 9.4,
10,10.4,
11, 11.4	-. Addition of
abutments having
small ball head
.: Identical except
	Head
Diameter (Ø)	1.7		Head
Diameter (Ø)	2.25	for head diameter
	Head
Length (H)	2.5		Head
Length (H)	3.35	and head length
S.E.	Similarities
Proposed Stud Abutment has same design, function and indications for use statement;
and is made with same material with same manufacturing method by same manufacturer
and is used for making overdenture retained restoration compared to that of the
predicated Stud Abutment (K161689).

Differences
Proposed Stud Abutment has shorter head length (H, in the image above) and smaller
head diameter compared to that of the predicated Stud Abutment. The shorter head
length of the proposed device allows space when producing overdenture. Except for this,
all dimensions are exactly same. However, the proposed abutment is straight type and it
does not received single load since it is used for overdenture so the load is dispersed;
therefore, we do not consider additional fatigue testing.

.: While proposed devices has shorter head length and smaller head diameter compared
to that of the predicated, proposed Stud Abutment and the predicated Stud Abutment
have common in design, function, indications for use, material, manufacturing process,
manufacturer, etc.; therefore, the proposed Stud Abutment is substantially equivalent to
the predicated Stud Abutment (K161689). | | | | | |

	O-ring	O-ring	Remark
510(k) No.	Proposed	Predicated (K161689)	-
Manufacturer	Osstem Implant Co., Ltd.	Osstem Implant Co., Ltd.	Identical
Design	Image: O-ring	Image: O-ring	Identical
Indications for Use
Statement	The Osstem Abutment System
is intended for use with a
dental implant to provide
support for prosthetic
restorations such as crowns,
bridges, or overdentures.	The OSSTEM Implant System

Abutment is intended for use
with a dental implant to
provide support for prosthetic
restorations such as crowns,
bridges, or overdentures. | Identical |

18

Image /page/18/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is written in orange, with a superscript "6" next to the "M". Below "OSSTEM", the word "IMPLANT" is written in gray. The logo is simple and modern.

| Principle of
Operation | Using inserted into retainer or
retainer cap and serves as a
buffer for abutments/implants
and denture fixation. | Using inserted into retainer or
retainer cap and serves as a
buffer for abutments/implants
and denture fixation. | Identical |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------|
| Material | NBR (Acrylonitrile &
Butadiene Polymer) | NBR (Acrylonitrile &
Butadiene Polymer) | Identical |
| Diameter (mm) | 3.5 | 4.6 | Different |
| S.E. | Similarities
Proposed O-ring has same design, function and indications for use statement; and is
made with same material with same manufacturing method by same manufacturer
compared to that of the predicated O-ring (K161689).
Differences
Proposed O-ring has smaller diameter compared to the predicated O-ring. It is used with
Stud Abutment that is smaller head length (proposed in this submission) together.
: While proposed device has smaller diameter compared to the predicated, proposed O-
ring and the predicated O-ring have common in design, function, indications for use,
material, manufacturing process, manufacturer, etc.; therefore, the proposed O-ring is
substantially equivalent to the predicated O-ring (K161689). | | |

	O-ring Retainer Cap	O-ring Retainer Cap	Remark
510(k) No.	Proposed	Predicated (K161689)	-
Manufacturer	Osstem Implant Co., Ltd.	Osstem Implant Co., Ltd.	Identical
Design	Image: O-ring Retainer Cap	Image: O-ring Retainer Cap	Identical
Indications for Use
Statement	The Osstem Abutment System
is intended for use with a
dental implant to provide
support for prosthetic
restorations such as crowns,
bridges, or overdentures.	The OSSTEM Implant System

Abutment is intended for use
with a dental implant to
provide support for prosthetic
restorations such as crowns,
bridges, or overdentures. | Identical |
| Principle of
Operation | Using inserted and fixed into
denture; and is connected with
abutment/implants. | Using inserted and fixed into
denture; and is connected with
abutment/implants. | Identical |
| Material | Titanium Gr. 3 (ASTM F67) | Titanium Gr. 3 (ASTM F67) | Identical |
| Diameter (mm) | 3.95 | 5 | Different |
| Height (mm) | 2.9 | 3.9 | Different |
| S.E. | Similarities | | |

19

Image /page/19/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and features the word "OSSTEM" in a bold, sans-serif font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, gray, sans-serif font. To the right of the word "OSSTEM" is a small, raised circle with the number 6 inside.

| Proposed O-ring Retainer Cap has same design, function and indications for use
statement; and is made with same material with same manufacturing method by same

manufacturer compared to that of the predicated O-ring Retainer Cap (K161689).
Differences
Proposed O-ring Retainer Cap has smaller diameter and height compared to the
predicated O-ring Retainer Cap. It is used with Stud Abutment that is smaller head
length (proposed in this submission) together.
.. While proposed device has smaller diameter and length compared to the predicated,
proposed O-ring Retainer Cap and the predicated O-ring Retainer Cap have common in
design, function, indications for use, material, manufacturing process, manufacturer,
etc.; therefore, the proposed O-ring Retainer Cap is substantially equivalent to the
predicated O-ring Retainer Cap (K161689).

	Port Abutment	LOCATOR RTx	Remark
510(k) No.	Proposed	Predicated (K150295)	-
Manufacturer	Osstem Implant Co., Ltd.	Zest Anchors, Inc.	Different
Design	Image: Port Abutment Design	Image: Locator RTX Design	Similar
Head part is where
connected to
overdenture and the
screw part is where
connected to the
implanted fixture.
Indications for Use
Statement	The Osstem Abutment System
is intended for use with a
dental implant to provide
support for prosthetic
restorations such as crowns,
bridges, or overdentures.	The LOCATOR® RTx Implant
Attachment System is
designed for use with
overdentures or partial
dentures, retained in whole or
in part, by endosseous
implants in the mandible or
maxilla.	The proposed
device and the
predicated device
has different
indication for use in
language, however
the difference in
language does not
change the intended
use or substantial
equivalence status.
Principle of
Operation	Using making implant retained
overdenture at
maxilla/mandible.	Using making implant retained
overdenture at
maxilla/mandible.	Identical
Material	Titanium Alloy
(Ti-6Al-4V, ASTM F136)	Titanium Alloy
(Ti-6Al-4V ELI)	Identical
Surface	Partial TiN coated in upper	TiCN or TiN coating	Within the range of
the predicates
Diameter (mm)	3.5 ~ 5.1	3.0 ~ 7.0	Within the range of
the predicates

20

Image /page/20/Picture/0 description: The image contains the logo for Osstem Implant. The logo is in orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray.

G/H (mm)	1 ~ 7	1 ~ 6	Exceed (bigger than) the range of the predicates
Abutment Angle	Straight	Straight	Identical
S.E.	Similarities
Proposed Port Abutment design, function, indications for use statement, is made with same material and is used for making overdenture retained restoration compared to that of the predicated LOCATOR RTx (K150295).

Differences
Dimension between the proposed and the predicates are different: proposed Port Abutment has diameter range from 3.5 to 5.1 whilte the predicated LOCATOR RTx has range from 3.0 to 7.0. Also, proposed Port Abutment has G/H range from 1 to 7 while the predicated LOCATOR RTx has range from 1 to 6.
Proposed Port Abutment has TiN coating on its surface while the predicated LOCATOR RTx has either TiCN or TiN coating on its surface. Proposed abutment is straight type, is intended for straight implantation, and is not received single load because this is used for making overdenture that means load is dispersed to the full denture; therefore, we do not consider additional fatigue testing.

∴ Proposed Port Abutment has similar design, function, and indication for use; and is made with same material compared to that of the predicated LOCATOR RTx (K150295). Since diameter and G/H of the proposed device are within or larger than the predicated device dimension, no additional safety and effectivencess evaluation is required. Therefore, the proposed Port Abutment and the predicated LOCATOR RTx is substantially equivalent each other. | | |

| | Port Angled Abutment &
Port Angled Abutment
Head | Multi Angled
Abutment | LOCATOR RTx | Remark | Design | | | | Different | | Port Male
Port Extended Male | Retention Insert | Remark |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|--------------------------------------|------------------------------------------|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|---------------------------------|----------------------|-----------|
| 510(k) No. | Proposed | Primary
Predicated
(K132067) | Reference
Predicated
(K150295) | - | Indications for
Use Statement | The Osstem Abutment
System is intended for use
with a dental implant to
provide support for
prosthetic restorations such
as crowns, bridges, or
overdentures. | Multi Angled
Abutment is
intended for use
with a dental
implant to provide
support for
prosthetic
restorations such
as bridges, or
overdentures. | The LOCATOR®
RTx Implant
Attachment System
is designed for use
with overdentures
or partial dentures,
retained in whole or
in part, by
endosseous
implants in the
mandible or
maxilla. | The proposed
device and the
predicated
device has
different
indication for
use in
language,
however the
difference in
language does
not change the
intended use or
substantial
equivalence
status. | 510(k) No. | Proposed | Predicated (K150295) | - |
| Manufacturer | Osstem Implant Co. Ltd. | | Zest Anchors,
LLC | Different | Principle of
Operation | Using making implant
retained overdenture needed
of path compensation at
maxilla/mandible. | Using making
screw-retained
type prosthesis in
multiple cases by
using with
Esthetic-low
cylinder when
path adjustment is
necessary. | Using for implant
retained
overdenture at
maxilla/mandible. | Similar | Manufacturer | Osstem Implant Co., Ltd. | Zest Anchors, Inc. | Different |
| Material | Titanium Alloy
(Ti-6Al-4V,
ASTM F136) | Titanium Alloy
(Ti-6Al-4V,
ASTM F136) | Titanium Alloy
(Ti-6Al-4V ELI) | Identical | Design | Image: Port Male Port Extended Male Design | Image: Retention Insert Design | Similar | | | | | |
| Diameter (mm) | 4.63 ~ 4.82 | 4.9 | 3.0 ~ 7.0 | Within the
range of the
predicates | Indications for Use
Statement | The Osstem Abutment System
is intended for use with a
dental implant to provide
support for prosthetic
restorations such as crowns,
bridges, or overdentures. | The LOCATOR® RTx Implant
Attachment System is
designed for use with
overdentures or partial
dentures, retained in whole or
in part, by endosseous
implants in the mandible or
maxilla. | The proposed
device and the
predicated device
has different
indication for use in
language, however
the difference in
language does not
change the intended
use or substantial
equivalence status. | | | | | |
| Abutment Angle | 10°/17°/30° | 17°/30° | Straight | Different | Principle of
Operation | Using inserted between Port
Abutment/Port Angled
Abutment and Port Male Cap
and takes a role to maintain
retention of overdenture. | Using inserted between
Locator RTx and dental
attachment housing and takes a
role to maintain retention of
overdenture. | Identical | | | | | |
| S.E. | Similarities
Proposed Port Angled Abutment has similar indications for use statement, design, function,
abutment angle, is made with same raw material, and is used for making overdenture | | | | Material | Nylon | Nylon or PEEK | Within the range of
the predicates | | | | | |

21

Image /page/21/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is written in large, bold, orange letters. Below it, the word "IMPLANT" is written in smaller, gray letters. A small superscript "6" is located to the right of the word "OSSTEM".

22

Image /page/22/Picture/0 description: The image shows the logo for Osstem Implant. The logo is orange and gray. The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray.

66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea Tel: +82 51 850 2500 Fax: +82 51 861 4693 www.osstem.com

retained restoration compared to that of the primary predicate device, Multi Angled Abutment (K132067). Proposed Port Angled Abutment has diameter which is within the range of the reference predicate device, LOCATOR RTx (K150295).

Differences

While proposed Port Angled Abutment has angle of 10, 17, and 30 degrees, the primary predicate device, Multi Angled Abutment has angle of 17 and 30 degrees; but the reference device, LOCATOR RTx is straight type abutment. Proposed Port Angled Abutment should be used connected by Port Angled Abutment Head together to place overdenture on top of the abutment but reference predicate. Since proposed Port Angled Abutment is used to make overdenture and does not receive single load because the load is dispersed to the denture; therefore, we do not consider additional fatigue testing.

·· Proposed Port Angled Abutment has similar indication for use, design, function, abutment angle, and is made with same raw material compared to that of the primary predicate device. Multi Angled Abutment (K132067): and it has diameter that is within the range of the reference predicate device, LOCATOR RTx (K150295). Therefore, the proposed Port Angled Abutment is substantially equivalent to the predicates.

23

Image /page/23/Picture/0 description: The image contains the logo for "OSSTEM IMPLANT". The word "OSSTEM" is in orange, and the word "IMPLANT" is in gray. The word "IMPLANT" is located directly below the word "OSSTEM".

	Similarities
	Proposed Port Male/Port Extended Male has similar design, function, indications for use
statement, and is made with one of same materials compared to that of the predicated
Retention Insert (K150295).
	Differences
S.E.	Proposed Male has 6 different types based on its retention levels while the predicated
Retention Insert has simplified 4 different types based on its retention levels from zero
to high.
	· Proposed Port Male/Port Extended Male has similar design, function, and indication
for use; and is made with one of same materials compared to that of the predicated
Retention Insert (K150295). Therefore, the proposed Port Male/Port Extended Male and
the predicated Retention Insert is substantially equivalent each other.

| | Port Male Cap | Denture Attachment
Housing | Remark |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | Proposed | Predicated (K150295) | - |
| Manufacturer | Osstem Implant Co., Ltd. | Zest Anchors, Inc. | Different |
| Design | Image: Port Male Cap | Image: Denture Attachment Housing | Similar |
| Indications for Use
Statement | The Osstem Abutment System
is intended for use with a
dental implant to provide
support for prosthetic
restorations such as crowns,
bridges, or overdentures. | The LOCATOR® RTx Implant
Attachment System is
designed for use with
overdentures or partial
dentures, retained in whole or
in part, by endosseous
implants in the mandible or
maxilla. | The proposed
device and the
predicated device
has different
indication for use in
language, however
the difference in
language does not
change the intended
use or substantial
equivalence status. |
| Principle of
Operation | Using fixing Port Male or Port
Extended Male by inserted into
the denture. | Using fixing Retention Insert
by inserted into the denture. | Identical |
| Material | Titanium Alloy
(Ti-6Al-4V, ASTM F136) | Titanium Alloy
(Ti-6Al-4 ELI) | Identical |
| S.E. | Similarities
Proposed Port Male Cap has similar design, function, indications for use statement, and
is made of same material compared to that of the predicated Denture Attachment
Housing (K150295). | | |

24

Image /page/24/Picture/0 description: The image shows the logo for OSSTEM IMPLANT. The word "OSSTEM" is in orange, with a small orange circle above the "M". Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and modern.

| | Differences
Proposed Port Male Cap is not applied of surface treatment while the predicated Denture
Attachment Housing has applied of pink anodizing on its surface. |
|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | :: Proposed Port Male Cap has similar design, function, and indication for use; and is
made with same material compared to that of the predicated Denture Attachment
Housing (K150295). Therefore, the proposed Port Male Cap and the predicated Dental
Attachment Housing is substantially equivalent each other. |

	EbonyGold Cylinder Screw	EbonyGold Cylinder Screw	Remark
510(k) No.	Proposed	Predicated (K120847)	-
Manufacturer	Osstem Implant Co., Ltd.	Osstem Implant Co., Ltd.	Identical
Design	Image: EbonyGold Cylinder Screw	Image: EbonyGold Cylinder Screw	Identical
Indications for Use
Statement	The Osstem Abutment System
is intended for use with a
dental implant to provide
support for prosthetic
restorations such as crowns,
bridges, or overdentures.	The abutment is intended for
use with a dental implant
fixture to provide support for
prosthetic restorations such as
crowns, bridges, or
overdenture.	Identical
Principle of
Operation	Using to connect a cylinder to
the abutment.	Using to connect a cylinder to
the abutment.	Identical
Material	Titanium Alloy
(Ti-6Al-4V, ASTM F136)	Titanium Alloy
(Ti-6Al-4V, ASTM F136)	Identical
Diameter (mm)	2.2, 2.5	2.2, 2.5	Identical
Length (mm)	4.35, 4.9	4.15, 4.7	Different
S.E.	Similarities
Proposed Abutment Screw has same design, function and indications for use statement;
and is made with same material with same manufacturing method by same manufacturer
compared to that of the predicated Abutment Screw (K120847).

Differences
Proposed Abutment Screw has same diameter, but longer in length compared to the
predicated Abutment Screw.

. While proposed device has longer in length compared to the predicated, proposed
Abutment Screw and the predicated Abutment Screw have common in design, function,
indications for use, material, manufacturing process, manufacturer, etc.; and the
difference does not affect to safety and effectiveness of the product. Therefore, the
proposed Abutment Screw is substantially equivalent to the predicated Abutment Screw
(K120847) | | |

25

Image /page/25/Picture/0 description: The image contains the word "OSSTEM" in orange, with the word "IMPLANT" in gray underneath. The number 6 is in superscript next to the word "OSSTEM". The logo is simple and modern.

| | Esthetic-low
Temporary
Cylinder | Esthetic-low
Temporary
Cylinder | Esthetic-low
Temporary
Cylinder | Remark |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) No. | Proposed | Predicated
(K062030) | Predicated
(K160670) | - |
| Manufacturer | Osstem Implant
Co., Ltd. | Osstem Implant
Co., Ltd. | Osstem Implant
Co., Ltd. | Identical |
| Design | Image: cylinder | Image: cylinder | Image: cylinder | Shape of post is
different |
| Indications for Use
Statement | The Osstem
Abutment System is
intended for use with
a dental implant to
provide support for
prosthetic
restorations such as
crowns, bridges, or
overdentures. | US system and SSII
mini are indicated
for use in partially or
fully edentulous
mandibles and
maxillae, in support
of single or multiple-
unit restorations
including; cemented
retained, screw
retained, or
overdenture
restorations, and
terminal or
intermediate
abutment support for
fixed bridgework.
US System is for
two stage surgical
procedures. It is not
for one stage surgery
or immediate load.
The SSII mini is for
one and two stage
surgical procedures.
It is not for
immediate load. | The OSSTEM
Prosthetic System is
intended for use with
a dental implant to
provide support for
prosthetic restoration
suc h as crowns,
bridges, or over-
dentures. | The proposed
device and the
predicated device
has different
indication for use
in language,
however the
difference in
language does
not change the
intended use or
substantial
equivalence
status |
| Principle of
Operation | Screw retained
restoration; using
making temporary
prosthesis before
loading final
prosthesis by
connected with
Multi Abutment, US
Multi Angled | Screw retained
restoration; using
making temporary
prosthesis before
loading final
prosthesis by
connected with
Multi Abutment, US
Multi Angled | Screw retained
restoration; using
making temporary
prosthesis before
loading final
prosthesis by
connected with
Multi Abutment, US
Multi Angled | Identical |
| | Abutment or
Esthetic-low
Abutment to make
overdenture and
bridge as multiple
cases. | Abutment or
Esthetic-low
Abutment to make
overdenture and
bridge as multiple
cases. | Abutment or
Esthetic-low
Abutment to make
overdenture and
bridge as multiple
cases. | |
| Material | Titanium Gr. 3
(ASTM F67) | Titanium Gr. 3
(ASTM F67) | Titanium Gr. 3
(ASTM F67) | Identical |
| Diameter (mm) | 4.8, 5.5 | 5.3, 6.0 | 4.8, 5.5 | Partial identical |
| Post Diameter (mm) | 3.7, 4.1 | 3.8, 4.2 | 3.35, 3.8 | Different |
| Length (mm) | 12 | 12 | 12 | Identical |
| Type | Standard Type | Standard Type | Narrow Type | Partial identical |
| Connection | External Hex | External Hex | External Hex | Identical |
| S.E. | Similarities
Proposed Esthetic-low Temporary Cylinder has same connection structure, function,
indications for use statement; and is made with same material with same manufacturing
method by same manufacturer and is used for making screw-retained restoration
compared to that of the predicated Esthetic-low Temporary Cylinder (K062030,
K160670).
Differences
Proposed Esthetic-low Temporary Cylinder is standard type, has smaller diameter, same
length, but different shape of post compared to that of the predicated Esthetic-low
Temporary Cylinder (K062030). However, it has same shape of post, diameter, length,
indication, etc., but bigger post diameter compared to that of the predicated narrow type
Esthetic-low Cylinder (K160670). Since proposed device is used temporarily and does
not have smallest diameter in this submission, we do not consider additional fatigue
testing.
• While proposed device has smaller diameter, same length, but different shape of post
compared to the predicated, proposed Esthetic-low Temporary Cylinder and the
predicated Esthetic-low Temporary Cylinder have common in function, indications for
use, material, manufacturing process, manufacturer, etc.; and the difference does not
raise safety and effectiveness issue. Therefore, the proposed Esthetic-low Temporary
Cylinder is substantially equivalent to the predicated Esthetic-low Temporary Cylinder
(K062030, K160670). | | | |

26

Image /page/26/Picture/0 description: The image contains the logo for Osstem Implant. The word "OSSTEM" is in orange, with a superscript "6" next to the "M". Below "OSSTEM" is the word "IMPLANT" in gray. The logo is simple and clean, with a focus on the company name.

	Temporary Cap	Temporary Cap	Remark
510(k) No.	Proposed	Predicated (K080594)	-
Manufacturer	Osstem Implant Co., Ltd.	Osstem Implant Co., Ltd.	Identical

27

Image /page/27/Picture/0 description: The image shows the logo for Osstem Implant. The word "OSSTEM" is written in orange, with the word "IMPLANT" written in gray below it. The logo is simple and modern, and it is likely used to promote the company's dental implant products.

| Design | | | Shape of post is
different |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use
Statement | The Osstem Abutment System
is intended for use with a
dental implant to provide
support for prosthetic
restorations such as crowns,
bridges, or overdentures. | The MS System (Narrow
Ridge) is intended to use in the
treatment of missing
mandibular central and lateral
incisors to support prosthetic
device, such as artificial teeth,
in order to restore chewing
function in partially
edentulous patients. MS
System (Narrow Ridge) are
intended for single use only. | The proposed
device and the
predicated device
has different
indication for use in
language, however
the difference in
language does not
change the intended
use or substantial
equivalence status |
| Principle of
Operation | Using making prosthetic
restoration temporarily by
protecting upper structure
while final prosthesis is made. | Using making prosthetic
restoration temporarily by
protecting upper structure
while final prosthesis is made. | Identical |
| Material | PC (Poly Carbonate) | PC (Poly Carbonate) | Identical |
| Diameter (mm) | 4 | 3.95
(4) | Identical
(within its tolerance
of ± 0.05) |
| Length (mm) | 9.6 | 9.6 | Identical |
| S.E. | Similarities
Proposed Temporary Cap has same basic structure, function, indications for use
statement; and is made with same material with same manufacturing method by same
manufacturer compared to that of the predicated Temporary Cap (K080594).
Differences
Proposed Temporary Cap has different shape of post compared to the predicated
Temporary Cap.
. · While proposed device has different shape of post compared to the predicated,
proposed Temporary Cap and the predicated Temporary Cap have common in function,
indications for use, material, manufacturing process, manufacturer, etc .; and the
difference does not raise safety and effectiveness issue. Therefore, the proposed
Temporary Cap is substantially equivalent to the predicated Temporary Cap (K080594). | | |

28

Image /page/28/Picture/0 description: The image shows the logo and contact information for OSSTEM Implant Co., Ltd. The logo includes the company name in bold, black font, with the word "OSSTEM" also appearing in orange next to the company name. Below the company name is the address: 66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, Republic of Korea, as well as the telephone number: +82 51 850 2500, fax number: +82 51 861 4693, and website: www.osstem.com.

1. Summary of Non-clinical Performance Testing
  Non-clinical testing data are submitted, referenced, or relied upon to demonstrate substantial equivalence.

Biocompatibility Evaluation

Biocompatibility testing was performed following the FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"and the ISO 10993 suite of standards.

Sterilization Validation

Subject devices are provided to the market in non-sterile status, and steam sterilization validation was considered according to ISO 17665-1.

Mechanical Properties

Fatigue testing was considered according to the FDA Guidance Document Guidance for Industry and FDA Staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment and ISO 14801 standard with the worst case scenario. Retention testing for dental attachments was conducted.

1. Summary of Clinical Testing
  No clinical studies are submitted.

9. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, OSSTEM IMPLANT Co., Ltd. concludes that Osstem Abutment System is substantially equivalent to the predicates devices as herein.