The EM SA Implant System (DENTURE) is intended to be place in the bone of the upper or lower jaw arches providing support to dental prosthetic devices, specifically for denture stabilization to restore a patient's chewing function. It is intended for single use only.

The EM SA Implant (NARROW RIDGE) is intended to be use in the treatment of missing mandibular central and lateral incisors to support dental prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. It is intended for single use only. It is intended for delayed loading.

Device Description

The EM SA Implant System is a dental implant made of titanium alloy (Ti-6AI-4V) and is supplied sterile. The surface treatment of EM SA Implant System is SA (Sandblasted and Acid etched) and is intended to be surgically placed in the bone of the upper or lower jaw arches.

The EM SA Implant System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. It is substantially equivalent in design, function and intended use to the OSSTEM Implant Co., Ltd.'s MS SA Implant System (K122171).

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for the Hiossen EM SA Implant System. This document asserts substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with performance metrics. Therefore, it does not contain the detailed information requested in the prompt regarding acceptance criteria, study design, sample sizes for test and training sets, data provenance, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies.

Here's an explanation of why the requested information is not available in the provided text:

510(k) Pre-market Notification: This regulatory pathway demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and performance characteristics to existing devices, rather than conducting new, comprehensive clinical performance studies to prove superiority or meet novel performance criteria as might be seen for PMA submissions or novel AI devices.
Medical Device Type: The EM SA Implant System is an endosseous dental implant, which is a physical device made of titanium alloy. The "device" in this context is a physical implant, not an AI/ML algorithm or software. Therefore, the questions related to AI/ML specific aspects like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," or "sample size for the training set" are not applicable.
Focus on Equivalence: The document's primary goal is to establish equivalence. It emphasizes that the new device uses the same materials, manufacturing processes, surface treatments, sterilization methods, and has similar designs to predicate devices. This implies that if the predicate devices meet safety and effectiveness standards, the new device, being substantially equivalent, should also.

Based on the provided text, here is what can be extracted or deduced regarding the evaluation process for this specific medical device submission, recognizing that it's not an AI/ML device and thus many questions are not directly applicable:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or precise performance metrics in the format typically seen for novel device performance studies. Instead, it aims to demonstrate substantial equivalence to predicate devices, implying that its performance is comparable and therefore acceptable.

A summary of the comparison to predicate devices, which serves as the basis for "acceptance" (of equivalence):

Feature	EM SA Implant System (Proposed Device)	MS SA Implant System (Primary Predicate, K122171)	Hiossen Implant System (Reference Device, K140934)
Intended Use	Denture: Support dental prosthetic devices for denture stabilization to restore chewing function. Single use only. Narrow Ridge: Treat missing mandibular central/lateral incisors to support prosthetic devices (artificial teeth) to restore chewing function in partially edentulous patients. Single use, delayed loading.	Denture: Support prosthetic devices to restore chewing function, including denture stabilization. Single use only. Narrow Ridge: Treat missing mandibular central/lateral incisors to support prosthetic devices to restore chewing function in partially edentulous patients. Single use, delayed loading.	General: Indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations (cemented retained, screw retained, or overdenture restorations), and final or temporary abutment support for fixed bridgework. Intended for delayed loading. Ultra wide Fixture System is intended for use in the molar region.
Material	Titanium alloy Ti-6Al-4V (ASTM F 136)	Titanium alloy Ti-6Al-4V (ASTM F 136)	Pure Titanium Grade 4 (ASTM F67)
Surface	SA (Sandblasted and Acid etched)	SA (Sandblasted and Acid etched)	SA (Sandblasted and Acid etched - for comparison), RBM (Resorbable Blast Media - also mentioned for MS System)
Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile
Packaging	Secured in plastic ampule, housed in Tyvek-lidded blister tray, placed in a tamper-evident outer package.	Secured in plastic ampule, housed in Tyvek-lidded blister tray, placed in an outer box.	Secured in plastic ampule, housed in Tyvek-lidded blister tray, placed in a tamper-evident outer package.
Design/Structure	Threaded Body Design, One Body Implant, specified gingival height neck, Ball-shaped head (for Denture) / Integrated abutment head (for Narrow Ridge). The document states the design is "very similar" to the MS SA.	Threaded Body Design, One Body Implant, specified gingival height neck, Ball-shaped head (for Denture) / Integrated abutment head (for Narrow Ridge).	Internal Hex-connected, Submerged Fixture, Tapered body shape & Straight body shape (This is a different design philosophy, used as a reference for aspects like sterilization and packaging, and general implant technology).
Diameters (mm)	Denture: Ø2.0, Ø2.5, Ø3.0 Narrow: Ø2.5, Ø3.0	Denture: Ø2.5, Ø3.0 Narrow: Ø2.5, Ø2.9	Ø3.5-6.8
Lengths (mm)	8.5, 10.0, 11.5, 13.0, 15.0	Denture: 10.0, 13.0, 15.0 Narrow: 8.5, 10.0, 13.0, 15.0	6.2-18.2

The document concludes that the proposed device is "substantially equivalent with respect to the intended use, structure, material, surface, sterilization and design with the legally marketed primary predicate device" and that "The slight difference in thread diameter and length is a simple size addition. The proposed device does not pose any new or increased risks as compared to the legally marketed primary predicate and reference devices."

2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not applicable. No clinical performance testing with a "test set" was submitted for this 510(k) pathway as per the document: "No clinical performance report(s) is being submitted."
Data Provenance: Not applicable. The submission relies on non-clinical data (biocompatibility, sterilization, shelf life, surface treatment, fatigue testing) which were either reasoned not necessary to re-test due to equivalence to predicates using identical processes and materials, or demonstrated compliance with international standards (e.g., ISO 11137 for sterilization, ISO 11607-1 for shelf life). These are laboratory/engineering tests, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. There was no clinical "test set" or requirement for expert-established ground truth mentioned in this 510(k) submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. No "test set" was used for clinical performance evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a physical dental implant, not an AI/ML software or system that would involve human "readers" or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical dental implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the clinical trial sense. The "ground truth" for this submission revolves around established engineering and material science standards. For example:
- Biocompatibility: Established by demonstrating the use of identical manufacturing processes and materials (titanium alloy Ti-6Al-4V, ASTM F 136) as the predicate device, which is a "well known and well established material." Compliance with ISO 10993 (Biological Evaluation of Medical Devices) is implied through equivalence.
- Sterilization Validation: Established by demonstrating identity to the predicate device in manufacturing process, material, sterile barrier system, and use of gamma radiation under the same conditions, validated following ISO 11137.
- Shelf Life: Established by demonstrating identical packaging materials & methods as a reference device (Hiossen Implant System, K140934) which had an 8-year shelf life validated per ISO 11607-1, and stating the device is medical grade titanium, non-mechanical, non-active.
- Surface Treatment Characterization: Established by demonstrating identical manufacturing process, material, and SA (Sandblasted, Acid etched) surface treatment as the predicate device.
- Fatigue Testing: Established by demonstrating identical manufacturing process, material, and "very similar design" to a predicate device (MS SA) that was fatigue tested in accordance with ISO 14801:2003.

8. The sample size for the training set

Not applicable. This device is a physical implant; there is no "training set" in the context of an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary

{0}------------------------------------------------

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

November 15, 2019

Hiossen, Inc. Peter Lee QA/RA Manager 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030

Re: K191201

Trade/Device Name: EM SA Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: November 14, 2019 Received: November 15, 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 (OS) 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 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 for Hiossen Implant. The word "Hiossen" is written in a sans-serif font, with the "H" in red and the rest of the letters in gray. A red swoosh appears above the "H". Below the word "Hiossen" is the word "IMPLANT" in smaller, gray letters.

85 Ben Fairless Drive airless Hills PA 19030 888-768-0001 www.hiossen.com

Section 5 Indication for Use Statement - 1 PAGE

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K191201 Device Name EM SA Implant System

Indications for Use (Describe)

Type of use (Select one or both, as applicable)

Z Prescription Use (Part 21 CFR 801 Subpart D)

[ Over-The-Counter Use (21 CFR 807 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)	Page 1 of 1	PSC Publishing Service (301) 443-6740 EF
----------------------	-------------	------------------------------------------

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is written in a stylized font, with the "H" in red and the rest of the letters in gray. The word "Implant" is written in smaller gray letters below the word "Hiossen". The logo is simple and modern, and it is likely used to promote the company's dental implant products.

510(k) Summary

K191201

(1) Submitter Information:Submitted by:	Hiossen, Inc.85 Ben Fairless DriveFairless Hills, PA 19030
Contact Person:Telephone Number:Fax Number:	Peter Lee267-759-7031267-759-7031
Date Prepared:	November 15, 2019
(2) Device Name:• Proprietary Name:• Classification Name:• CFR Number:• Device Class:• Product Code:	EM SA Implant SystemEndosseous dental implant872.3640Class IIDZE

(3) Predicate Devices:

	Device	510(k)	Manufacturer
Primary Predicate	MS SA Implant System	K122171	OSSTEM
Reference Device	MS System	K083067/K072959	OSSTEM
Reference Device	Hiossen Implant System	K140934	HIOSSEN

(4) Description of Device:

Device	Thread Diameter(mm)	Thread Length(mm)
EM SA Implant System (Denture)	Ø2.0, Ø2.5, Ø3.0	8.5, 10.0, 11.5, 13.0, 15.0
EM SA Implant System (Narrow Ridge)	Ø2.5, Ø3.0	8.5, 10.0, 11.5, 13.0, 15.0

(5) Indication For Use:

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is written in a stylized font, with the "H" in red and the rest of the letters in gray. The word "Implant" is written in smaller gray letters below "Hiossen". There is a registered trademark symbol next to the word "Hiossen".

85 Ben Fairless Drive Fairless Hills, PA 19030 888-768-0001 www.hiossen.com

(6) Substantial Equivalence:

HIOSSEN believes the EM SA Implant System is substantially equivalent to the primary predicate device, OSSTEM MS SA Implant System in November 2012 (510(k) number K122171).

	Proposed Device	Primary Predicate	Reference Device	Reference Device
Device	EM SA Implant	MS SA System	MS System	HIOSSEN IMPLANT
	System (Denture)	(Denture)		SYSTEM
Manufacturer	Hiossen, Inc.	Osstem Co., Ltd.	Osstem Co., Ltd.	Hiossen, Inc.
510(K) No.	New device	K122171	K083067/K072959	K140934
Design
Intended use	The EM SA ImplantSystem (DENTURE)is intended to beplace in the bone ofthe upper or lowerjaw arches providingsupport to dentalprosthetic devices,more specificallydenture stabilizationto restore a patient'schewing function. It isintended for singleuse only.	The MS System(Denture) is intendedto be place in thebone of the upper orlower jaw arches toprovide support theprosthetic devices torestore the patient'schewing function,including the denturestabilization. The MSSystem (Denture) isintended for singleuse only.	The MS System(Denture) is intendedto be place in thebone of the upper orlower jaw arches toprovide support theprosthetic devices torestore the patient'schewing function,including the denturestabilization. The MSSystem (Denture) isintended for singleuse only.	The HIOSSENImplant System isindicated for use inpartially or fullyedentulous mandiblesand maxillae, insupport of single ormultiple-unitrestorations including;cemented retained,screw retained, oroverdenturerestorations, and finalor temporaryabutment support forfixed bridgework. It isintended for delayedloading. Ultra wideFixture System isintended to be usedin the molar region.
Structure	• Threaded BodyDesign• One Body Implant• 2/4mm gingivalheight neck• Ball-shaped headfor O-Ringattachment.	• Threaded BodyDesign• One Body Implant• 2/4mm gingivalheight neck• Ball-shaped headfor O-Ringattachment.	• Threaded BodyDesign• One Body Implant• 2/4mm gingivalheight neck• Ball-shaped headfor O-Ringattachment.	• Internal Hex-connected• Submerged Fixture• Tapered bodyshape & Straightbody shape
Thread	2.0, 2.5, 3.0	2.5, 3.0	2.0 ~ 3.0	3.5~6.8
Diameters
ThreadLengths	8.5, 10.0, 11.5, 13.0,15.0	10.0, 13.0, 15.0	8.5, 10.0, 13.0, 15.0	6.2~18.2
Material	Titanium alloy Ti-6Al-4V (ASTM F 136)	Titanium alloy Ti-6Al-4V (ASTM F 136)	Titanium alloy Ti-6Al-4V (ASTM F 136)	Pure Titanium Grade4 (ASTM F67)
Surface	SA (Sandblasted andAcid etched).	- SA(Sandblastedand Acid etched)	RBM (ResorbableBlast Media)	- SA(Sandblastedand Acid etched)
Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile	Radiation Sterile
Packaging	Secured in plasticampule, housed inTyvek-lidded blistertray, placed in atamper-evident outerpackage.	Secured in plasticampule, housed inTyvek-lidded blistertray, placed in a outerbox.	Secured in plasticampule, housed inTyvek-lidded blistertray, placed in a outerbox.	Secured in plasticampule, housed inTyvek-lidded blistertray, placed in atamper-evident outerpackage.
S.E.	The proposed device is substantially equivalent with respect to the intended use, structure,material, surface, sterilization and design with the legally marketed primary predicate device aswell as the surface, sterilization and packaging of the legally marketed reference device. Theslight difference in thread diameter and length is a simple size addition. The proposed devicedoes not pose any new or increased risks as compared to the legally marketed primarypredicate and reference devices.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Hiossen Implant. The word "Hiossen" is written in a stylized font, with the "H" in red and the rest of the letters in gray. The word "Implant" is written in gray below "Hiossen". The logo is simple and modern, and it is likely used to promote the company's dental implant products.

Device	Proposed DeviceEM SA ImplantSystem(Narrow Ridge)	Primary PredicateMS SA ImplantSystem(Narrow Ridge)	Reference DeviceMS System	Reference DeviceHIOSSEN IMPLANTSYSTEM
Manufacturer	Hiossen, Inc.	Osstem Co., Ltd.	Osstem Co., Ltd.	Hiossen, Inc.
510(K) No.	New device	K122171	K083067	K140934
Design	Image: Proposed Device EM SA Implant System (Narrow Ridge)	Image: Primary Predicate MS SA Implant System (Narrow Ridge)	Image: Reference Device MS System	Image: Reference Device HIOSSEN IMPLANT SYSTEM
Intended use	The EM SA ImplantSystem (NARROWRIDGE) is intendedto be use in thetreatment of missingmandibular centraland lateral incisors tosupport dentalprosthetic devices,such as artificialteeth, in order torestore chewingfunction in partiallyedentulous patients.It is intended forsingle use only. It isintended for delayedloading.	The MS SA ImplantSystem (NarrowRidge) is intended touse in the treatmentof missingmandibular centraland lateral incisors tosupport prostheticdevice, such asartificial teeth, inorder to restorechewing function inpartially edentulouspatients. The MS SAImplant (NarrowRidge) is intended forsingle use only. It isintended for delayedloading.	The MS ImplantSystem (NarrowRidge) is intended touse in the treatmentof missingmandibular centraland lateral incisors tosupport prostheticdevice, such asartificial teeth, inorder to restorechewing function inpartially edentulouspatients. MS Implant(Narrow Ridge) isintended for singleuse only. It isintended for delayedloading	The HIOSSENImplant System isindicated for use inpartially or fullyedentulousmandibles andmaxillae, in supportof single or multiple-unit restorationsincluding; cementedretained, screwretained, oroverdenturerestorations, and finalor temporaryabutment support forfixed bridgework. It isintended for delayedloading. Ultra wideFixture System isintended to be used

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the Hiossen Implant logo. The word "Hiossen" is written in a stylized font, with the "H" in red and the rest of the letters in gray. The word "Implant" is written in gray below "Hiossen". There is a registered trademark symbol next to the word "Hiossen".

				in the molar region.
Structure	• Threaded BodyDesign• One Body Implant• 2.5/4mm gingivalheight neck• Integrated abutmenthead	• Threaded BodyDesign• One Body Implant• 2.5/4mm gingivalheight neck• Integrated abutmenthead	• Threaded BodyDesign• One Body Implant• 2/4mm gingivalheight neck• Integrated abutmenthead	• Internal Hex-connected• Submerged Fixture• Tapered bodyshape & Straightbody shape
ThreadDiameters	2.5, 3.0	2.5, 2.9	2.5, 3.0	3.5~6.8
ThreadLengths	8.5, 10.0, 11.5, 13.0,15.0	8.5,10.0, 13.0, 15.0	8.5, 10.0, 13.0, 15.0	6.2~18.2
Material	Titanium alloy Ti-6Al-4V (ASTM F 136)	Titanium alloy Ti-6Al-4V (ASTM F 136)	Titanium alloy Ti-6Al-4V (ASTM F 136)	Pure Titanium Grade4 (ASTM F67)
Surface	- SA(Sandblastedand Acid etched)	- SA(Sandblastedand Acid etched)	RBM (ResorbableBlast Media)	- SA(Sandblastedand Acid etched)
Sterilization	Radiation Sterile	Radiation Sterile	Radiation Sterile	Radiation Sterile
Packaging	Secured in plasticampule, housed inTyvek-lidded blistertray, placed in atamper-evident outerpackage.	Secured in plasticampule, housed inTyvek-lidded blistertray, placed in aouter box.	Secured in plasticampule, housed inTyvek-lidded blistertray, placed in aouter box.	Secured in plasticampule, housed inTyvek-lidded blistertray, placed in atamper-evident outerpackage.
S.E.	The proposed device is substantially equivalent with respect to the intended use, structure,material, surface, sterilization and design with the legally marketed primary predicate deviceas well as the surface, sterilization and packaging of the legally marketed reference device.The slight difference in thread diameter and length is a simple size addition. The proposeddevice does not pose any new or increased risks as compared to the legally marketed primarypredicate and reference devices

Non-Clinical Performance Data

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include data from the following tests:

Biocompatibility Testing

The EM SA Implant System is manufactured using the same manufacturing process and same well known and well established material as the primary predicate device, the MS SA Implant System, K122171, therefore we reason it was not necessary to re-test biocompatibility in order to support the biological safety of the EM SA Implant System. Furthermore, as described in International Standard Organization (ISO) standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing when a new material is used that has not been identified in a primary predicate device. The proposed device is manufactured from standard raw material that is used in the primary predicate device and other currently marketed dental implant system. Therefore, no additional biocompatibility testing is required to establish substantial equivalence.

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image is a logo for Hiossen Implant. The word "Hiossen" is written in a sans-serif font, with the "H" in red and the rest of the letters in gray. There is a red curved line above the "H". Below "Hiossen" is the word "IMPLANT" in smaller gray letters. There is a registered trademark symbol next to the word "Hiossen".

ww.hiossen.com

Sterilization Validation

The EM SA Implant System (manufactured using the same manufacturing process, material and utilizes the same sterilize barrier system) is gamma irradiated under the same conditions and process as the primary predicate device, the MS SA Implant System, K122171 and validated following ISO 11137 [2006] Sterilization of health care products - Requirements for Validation and Routine control - Radiation Sterilization quidelines, therefore we reason it was not necessary to re-test validation in order to support the sterilization validity of the EM SA Implant System.

Shelf Life

The EM SA shelf life is identical to the reference device HIOSSEN Implant System which has been validated for eight (8) years following ISO 11607-1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems. The EM SA utilizes the exact same packaging materials & methods and is a medical grade titanium, nonmechanical, non-active device, therefore, degradation in performance characteristics is not likely over the established shelf life period. Therefore, no shelf-life validation or accelerated aging testing was performed.

Surface Treatment Characterization Testing

The EM SM Implant System is manufactured using the same manufacturing process, material and well known and well established surface treatment, SA (Sand blasted, Acid etched) as the predicate device, the MS SA Implant system, K122171, therefore no additional character testing was necessary to support the equivalency of the EM SA Implant System.

Fatique Testing

The EM SA Implant System is manufactured using the same manufacturing process, material and very similar design, as the MS SA which was fatique tested in accordance with ISO 14801:2003 Dentistry -Fatigue Test for Endosseous Dental Implants, we reason it was not necessary to re-test fatigue.

Clinical Performance Testing

No clinical performance report(s) is being submitted.

(7) Conclusion:

In accordance with the Federal Food Drug and Cosmetic Act, 21 CFR Part 807, and based on the data and information provided in this premarket notification, the proposed device, EM SA Implant System has established substantially equivalency to the primary predicate and reference device. An extensively comparison of the same design, intended use, structure, general shape and size, material and application method confirms the EM SA share many similarities with the primary predicate MS SA Implant System (K122171) and utilize the same sterilization method and packaging materials to the reference device Hiossen Implant System (K140934). The additional thread diameter and length is a simple size addition, a risk and mitigation measure for root-form endosseous dental implant in a FMEA risk analysis did not disclose any safety or health risk.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.