K Number

Device Name

IR Type Implant System

Manufacturer

Biotem Co., Ltd.

Date Cleared

2017-12-01

(221 days)

Product Code

DZE NHA

Regulation Number

872.3640

Intended Use

IR Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. IR Type Implant System is for one stage surgical procedures. It is intended for delayed loading. IR Implant System is intended only for straight placement with no correction of angulation.

Device Description

IR Type Implant System is a dental implant system made of of CP Ti Gr. 4 intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implant may be used to replace one or more missing teeth. The 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. The surface of the system has been treated with R.B.M (Resorbable Blast Media).

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K062051

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard dental implant system and does not mention any AI or ML components, image processing, or data analysis related to AI/ML.

Therapeutic

Yes
The device is described as an "IR Type Implant System" that is "intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period." It is designed to "replace one or more missing teeth," which are actions aimed at the alleviation of a disease (loss of teeth) or conditions.

Diagnostic

Explanation: The device description states it is a dental implant system (IR Type Implant System) intended to be surgically placed in the bone to replace missing teeth, indicating a therapeutic or reconstructive function rather than a diagnostic one.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "dental implant system made of CP Ti Gr. 4 intended to be surgically placed in the bone," indicating it is a physical hardware device, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Description: The provided text describes a dental implant system that is surgically placed in the bone of the jaw. This is a surgical implant, not a device that analyzes samples taken from the body.
Intended Use: The intended use clearly states it's for supporting dental restorations in the mouth, which is a surgical and prosthetic application, not an in vitro diagnostic one.

The information provided focuses on the surgical placement, material, and mechanical properties of the implant, which are characteristic of a medical device used within the body, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DZE, NHA

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mandibles and maxillae

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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:

Sterilization Validation testing for sterile devices (fixtures) performed in accordance with ISO11137, ISO 11737-1 & ISO 11737-2 for gamma sterilization.
Steam Sterilization validation for non-sterile devices (abutments) performed in accordance with ISO 17665-1 and IS 17665-2.
Surface Characteristics Test Report - Chemical and SEM image analyses performed to verify no residual after RBM treatment on the fixtures.
Cytotoxicity Test performed according to ISO 10993-5:2009.
Sensitization test performed according to ISO 10993-10:2010.
LAL Endotoxin lot release testing according to USP .
Shelf Life Testing performed according to ISO 11607.

Key Results: The results of the above tests have met the criteria of the standard, and proved the substantial equivalence with the predicate device. The results of the non-clinical testing demonstrate that the subject device is substantially equivalent to the predicate device.

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

Not Found

Predicate Device(s)

K062051

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

December 1, 2017

Biotem Co., Ltd. % Joyce Bang Consultant Provision Consulting Group, Inc. 14071 Peyton Dr. #967 Chino Hills, California 91709

Re: K171185

Trade/Device Name: IR Type Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 28, 2017 Received: October 31, 2017

Dear Joyce Bang:

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. 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.

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew I. Steen -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K171185

Device Name IR Type Implant System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K171185510(k) Summary

15. 510(K) SUMMARY

Submitter:

Hong Koo Yeo Biotem Co., Ltd . 57, Sasang-ro , 401 beon-gil , Sasang-gu , Busan , Korea Tel : +82-70-8220-4934 Fax : +82-51-908-8257

Official Correspondent/ US Agent:

Joyce Bang Provision Consulting Group, Inc. 14071 Peyton dr. #967 Chino Hills, CA 91709

Prepared Date: 11-30-2017

Device Information:

Device Name: IR Type Implant System Classification Name: Endosseous Dental Implant Common Name: Endosseous Dental Implant Classification: Class II Product Code: DZE Subsequent Product Code: NHA Regulation number: 21 CFR 872.3640

Predicate Device:

SS System (K062051) manufactured by Osstem Implant Co., Ltd.

Indications for use

IR Type Implant 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 overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. IR Type Implant System is for one stage surgical procedures. It is intended for delayed loading. R Implant System is intended only for straight placement with no correction of angulation.

Device Description

Endosseous Diameter	Endosseous Length(mm)
Ø3.5	8.5, 10.0, 11.5, 13.0, 15.0
Ø 4.1	7.5, 8.5, 10.0, 11.5, 13.0, 15.0
Ø 4.8	7.5, 8.5, 10.0, 11.5, 13.0, 15.0
Ø 5.5	7.5, 8.5, 10.0, 11.5, 13.0, 15.0

Substantial Equivalence Comparison Chart

		Subject Device	Predicate Device
510(k) Number		Not available yet	K062051
Device Name		IR Type Implant System	SS System
Manufacturer		Biotem Co., Ltd.	Osstem Implant Co., Ltd.
Indications for Use		IR Type Implant 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
overdenture restorations, and
terminal or intermediate abutment
support for fixed bridgework. IR
Type Implant System is for one stage
surgical procedures. It is intended for
delayed loading. IR Implant System is
intended only for straight placement
with no correction of angulation.	SS System is intended 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. SS
System is for one stage surgical
procedures. It is not for immediate
load.
Design		Internal Octa Tapered	Internal Octa Tapered
Material		CP Ti Gr 4 ASTM F67	CP Ti Gr 4 ASTM F67
Sterilization		Gamma sterilization	Gamma sterilization
Fixture Diameter (mm)		Ø 3.5, 4.1, 4.8, 5.5	Ø 3.5-6.0
Fixture Length (mm)		7.5, 8.5, 10.0, 11.5, 13.0, 15.0	6.0-15.0
	Diameters	Ø 4.8, 6.0, 6.5 mm	Ø 4.8, 6.0, 6.5 mm
	Lengths	2.0, 3.0, 4.0, 5.5, 6.0, 7.0mm	2.0, 4.0, 5.5, 7.0mm
Abutment	Angled	0°	20°
Attachment		Various abutments and components	Various abutments and components
Surface treatment		RBM	RBM
Product Code		DZE NHA	DZE NHA

Basis for Substantial Equivalence

IR Type Implant System has a substantially equivalent intended use as the identified predicate (K062051). Both are used for mandible and maxilla endosseous dental implant and accessories. The IR Type Implant System is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with FDA's Class II special controls guidance document root-form endosseous dental implants and endosseous dental implant abutments.

The subject and predicate devices are similar in size, surface treatment and materials. When compared with predicate devices, no new questions of substantially equivalence have been raised for the IR Type Implant System.

Non- Clinical Testing

The subject device was tested to evaluate its performance as below.

Sterilization Validation testing for sterile devices (fixtures) has been performed in accordance with ISO11137, ISO 11737-1& ISO 11737-2 for gamma sterilization
Steam Sterilization validation for non-sterile devices (abutments) has been performed in accordance with ISO 17665-1 and IS 17665-2.

• Surface Characteristics Test Report - Chemical and SEM image analyses have been performed to verify that there is no residual after RBM treatment on the fixtures.

· Cytotoxicity Test performed according to ISO 10993-5:2009
· Sensitization test performed according to ISO 10993-10:2010
LAL Endotoxin lot release testing according to USP
· Shelf Life Testing performed according to ISO 11607

Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The result of the above tests have met the criteria of the standard, and proved the substantial equivalence with the predicate device. Non- clinical testing consisted of performance of testing in accordance with the FDA guidance "Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of the non-clinical testing demonstrate that the subject device is substantially equivalent to the predicate device

Conclusion

The subject devices and the predicate devices have the similar intended use and have the similar technological characteristics. The subject and predicate implants are all made of commercially pure titanium and have the similar surface treatments. Overall, the IR Implant System has the following similarities to the predicate devices:

has the similar me intended use,
· uses the similar operating principle,
· incorporates the similar basic design,
incorporates the similar material and the surface treatment.

Based on the similarities, we conclude that the IR Implant System is substantially equivalent to the predicate device.