Who is the manufacturer of TS FIXTURE SYSTEM?

Osstem Implant Co., Ltd. filed the 510(k) submission for TS FIXTURE SYSTEM (K121995).

What is the FDA product code for TS FIXTURE SYSTEM?

DZE. It is classified under 21 CFR 872.3640 as a Class 2 device in the Dental panel.

What is the regulatory pathway for TS FIXTURE SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for TS FIXTURE SYSTEM?

HGII Fixture System (K090237); ETIII SA Fixture System (K101096); GSIII System (K091208); ETIII SA Ultra wide Fixture (K103537).

Who can help prepare an FDA 510(k) submission like TS FIXTURE SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TS FIXTURE SYSTEM

K121995 · Osstem Implant Co., Ltd. · DZE · Nov 29, 2012 · Dental

Device Facts

Record ID	K121995
Device Name	TS FIXTURE SYSTEM
Applicant	Osstem Implant Co., Ltd.
Product Code	DZE · Dental
Decision Date	Nov 29, 2012
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3640
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The TS Fixture 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

Device Story

TS Fixture System is a titanium dental implant surgically placed into maxillary or mandibular alveolar bone to replace lost teeth. Device features internal hex connection, tapered or straight body, and self-tapping 4-sided cutting edge. Available in various lengths (7.0-15.0mm) and diameters (3.5-6.8mm). Surface treated via sandblasting and acid etching (SA). Used by dentists in clinical settings for one or two-stage surgical procedures. After osseointegration, fixture connects to abutment posts to support prosthetic restorations. Benefits include restoration of dental function and aesthetics for edentulous patients.

Clinical Evidence

No clinical studies submitted. Bench testing only, including fatigue testing per FDA guidance for root-form endosseous dental implants.

Technological Characteristics

Material: Pure Titanium Grade 4 (ASTM F67). Surface: SA (Sandblasting and Acid etching). Design: Internal hex-connected, submerged, tapered/straight body, self-tapping. Sterilization: Radiation. Dimensions: Length 7.0-15.0mm, Diameter 3.5-6.8mm.

Indications for Use

Indicated for partially or fully edentulous adult patients requiring single or multiple-unit dental restorations, including cemented, screw-retained, or overdenture restorations, and fixed bridgework support. Intended for delayed loading.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

HGII Fixture System (K090237)
ETIII SA Fixture System (K101096)
GSIII System (K091208)
ETIII SA Ultra wide Fixture (K103537)

Related Devices

K121585 — TS IMPLANT SYSTEM · Osstem Implant Co., Ltd. · Jan 7, 2013
K123471 — ETII SA FIXTURE SYSTEM · Hiossen, Inc. · Jul 5, 2013
K101096 — HT III SA FIXTURE SYSTEM · Hiossen, Inc. · Oct 8, 2010
K202046 — LOTA SLA Dental Implant System and LOTA HA Dental Implant System · Kj Meditech Co., Ltd. · Mar 1, 2022
K161923 — J2A SLA Dental Implant System · Kj Meditech Co., Ltd. · Nov 9, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ K121995 OSSTEM Implant Co., #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com NOV 2 9 2012 ## 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: June 15, 2012 1. Company and Correspondent making the submission: - Submitter's Name : - Address : - Contact : - Phone: - Correspondent's Name: - Address: - Contact: - Phone: - 2. Device : Trade or (Proprietary) Name : Common or usual name : Classification Name : OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804, Republic of Korea Mr. Hee Kwon Son +82 51 850 2575 HIOSSEN Inc. 85 Ben Fairless Dr. Fairless Hills, PA 19030 Patrick Lim 888 678 0001 TS Fixture System Dental Implant Endosseous Dental Implant 21CFR872.3640 Class II DZE ### 3. Predicate Device: The HGII Fixture System, HIOSSEN Inc., Ltd. K090237 The ETIII SA Fixture System, HIOSSEN Inc., K101096 The GSIII System, Osstem Implant Co., Ltd, K091208 The ETIII SA Ultra wide Fixture, HIOSSEN Inc., K103537 ### 4. Description: The TS Fixture System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is available in various lengths 7.0 to 15.0mm and diameters 3.5 to 6.8mm (TSII SA Fixture : 3.5, 4.2, 4.4, 4.9 / TSIII SA Fixture: 3.75, 3.77, 4.2, 4.25, 4.6, 4.63, 4.65, 5.05, QS-QI-505-3(Rev.0) Letter(8.5 X 11in) {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for OSSTEM IMPLANT. The word "OSSTEM" is in bold, sans-serif font, with the letters slightly overlapping. Below "OSSTEM" is the word "IMPLANT" in a smaller, lighter font. There is a small circle to the upper right of the word "OSSTEM". OSSTEM Implant Co., Lt #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com 5.08, 5.1 / TSIII SA Ultra-Wide Fixture : 5.92, 5.95, 6, 6.8) according to the anatomical situation. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. The TS Fixture 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 TS Fixture System is substantially equivalent in design, function and intended use to the HGII Fixture System of HIOSSEN Inc. (K090237), the ETIII SA Fixture System of HIOSSEN Inc.(K101096), The GSIII System of Osstem Implant Co., Ltd(K091208) and The ETIII SA Ultra wide Fixture of HIOSSEN Inc.(K103537) ### - Substantial Equivalence Matrix | | | Predicate devices | | | | TSIII SA Ultra-Wide Fixture | Predicate devices | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | TS Fixture System | HGII Fixture System | GSIII System | ETIII SA Fixture System | | | ETIII SA Ultra wide Fixture | | Design | | | | | Design | Image: TSIII SA Ultra-Wide Fixture | Image: ETIII SA Ultra wide Fixture | | 510(K) No. | New Device | K090237 | K091208 | K101096 | 510(K) No. | New Device | K103537 | | Intended use | The TS Fixture System is designed for dental implant surgery; it is placed on the maxillary or mandibular alveolar bone through a surgical procedure, and after osseointegration with the alveolar bone, it can replace a lost tooth by connecting the abutment post. The TS Fixture System is indicated for use in partially or fully edentulous mandibles | The HG II Fixture 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 | The GS III 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 | ETIII SA Fixture 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 | Intended use | The TSIII SA Ultra-Wide Fixture 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. | The ETIII SA Ultra wide 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. | | | of single or multiple- unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. | for fixed bridgework. The HG II Fixture System is for single and two stage surgical procedures. It is not for immediate load. | for fixed bridgework. The GS III System is for single and two stage surgical procedures. It is not for immediate load. | support for fixed bridgework. The ETIII SA Fixture System is for single and two stage surgical procedures. It is not for immediate load. The Ultra wide Fixture System is intended to be used in the molar region. | Surgery type | One or two stage Surgery | One or two stage Surgery | | Surgery type | One or two stage Surgery | One or two stage Surgery | One or two stage Surgery | One or two stage Surgery | Structure | - Internal Hex-connected - Submerged Fixture - Tapered body shape and straight body shape - 4 sided cutting edge with self-tapping | - Internal Hex-connected - Submerged Fixture - Tapered body shape and straight body shape - 4 sided cutting edge with self-tapping | | Structure | - Internal Hex- connected - Submerged Fixture - Tapered body shape and straight body shape - 4 sided cutting edge with self-tapping | - Internal Hex- connected - Submerged Fixture - Straight body shape - 4 sided cutting edge with self- tapping | - Internal Hex- connected - Submerged Fixture - Tapered body shape and - 4 sided cutting edge with self- tapping | - Submerged Fixture - Self tapping - Internal Hexagonal connection - Taper Body | Body Diameter (D) | 5.92, 5.95, 6, 6.8 | 5.9~6.82 | | Body Diameter (D) | TSII SA Fixture: 3.5, 4.2, 4.4, 4.9 TSIII SA Fixture: 3.75, 3.77, 4.2, 4.25, 4.6, 4.63, 4.65, 5.05, 5.08, 5.1 | 3.5~4.85 | 3.7~5.1 | 3.75~5.05 | Length (mm) | 7.0~12.5 | 7.2~12.7 | | Length (mm) | 7.0~15 | 7.2~15.2 | 7.0~15.0 | 7.2~15.2 | Material of Fixture | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) | | Material of Fixture | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) | Pure Titanium Grade 4 (ASTM F67) | Surface | SA (Sandblasting and Acid etching) | SA (Sandblasting and Acid etching) | | Surface | SA | RBM | RBM | SA | Sterilization | Radiation Sterile | Radiation Sterile | | Sterilization | Radiation Sterile | Radiation Sterile | Radiation Sterile | Radiation Sterile | Shelf life | 8years | 5years | | Shelf life | 8years | 5 years | 5 years | 5 years | S E | The TSIII SA Ultra-Wide Fixture has the same material, surface treatment, indication for use and similar design as the ETIII SA Ultra wide Fixture (K103537) | | | S. E. | The TS Fixture System has the same material, indication for use and similar design as the HGII Fixture System (K090237) and GSIII System (K091208) except surface treatment. but the surface treatment of TS Fixture System is the same with surface treatment of ETIII SA Fixture System (K101096) | | | | | | | OS-QI-505-3(Rev.0) Letter(8.5 X 11in) {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Osstem Implant. The logo is in black and white and features the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller, simpler font. There is a circle above and to the right of the word "OSSTEM". OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com QS-QI-505-3(Rev.0) Letter(8.5 X 11in) . {3}------------------------------------------------ OSSTEM® IMPLANT OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com A The School States States of Article (6) -- {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for OSSTEM IMPLANT. The logo is in black and white, with the word "OSSTEM" in large, bold letters. Below the word "OSSTEM" is the word "IMPLANT" in smaller letters. There is a degree symbol to the right of the word OSSTEM. OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com #### 5. Indication for use : The TS Fixture 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. TS Fixture System is compatible with abutment in the ET/SS Implant System - 6. Review : The TS Fixture System has same material and indication for use and similar design and technological characteristics as the predicate device. The TS Fixture System has been subjected to safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations. #### 7. Summary of nonclinical testing Fatigue testing was considered according to the "Guidance for industry and FDA staff Class II Special Controls Guidance Document Root-form Endosseous Dental Implants and Endosseous Dental Abutment" with the worst case scenario of the GSIII Fixture/ the HGII Fixture and an angled abutment in support of the TSIII SA Fixture and TSII SA Fixture. TS Fixture System has same material and similar design as the GSIII Fixture and the HGII Fixture . Therefore, submitted fatigue test result can be used as a proof of TS Fixture system 8. Summary of clinical testing No clinical studies are submitted #### 9. Conclusions 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 the TS Fixture System is substantially equivalent to the predicate devices as described herein {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, composed of three curved lines. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002 November 29, 2012 Osstem Implant Company, Limited C/O Mr. Patrick Lim Hiossen, Incorporated 85 Ben Fairless Drive Fairless Hills, Pennsylvania 19030 Re: K121995 Trade/Device Name: TS Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II · Product Code: DZE Dated: November 9, 2012 . Received: November 23, 2012 Dear Mr. Lim: 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. {6}------------------------------------------------ ### Page 2 - Mr. Lim 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. # Kwame O. Ulmer Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ OSSTEM Implant Co., Ltd. #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com 510(k) Number K 121995 Device Name : TS Fixture System Indication for use : The TS Fixture 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 final or temporary abutment support for fixed bridgework. It is intended for delayed loading. > TS Fixture System is compatible with abutment in the ET/SS Implant System Prescription Use X (Per 21CFR801 Subpart D) Over-The-Counter Use OR (Per 21CFR807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Runner DDS, MA 2012.11.29 12:46:27 -05'00' (Division Sign-Off) (Division Sign-off) Division of Anestheslology, General Hospital Infection Control, Dental Devices 510(k) Number: QS-QI-505-2(Rev.0) Letter(8.5 X 1 l in) 11