← Product Code [NHA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA) · K123755 # MULTI ANGLED ABUTMENT (K123755) _Osstem Implant Co., Ltd. · NHA · Apr 26, 2013 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K123755 ## Device Facts - **Applicant:** Osstem Implant Co., Ltd. - **Product Code:** [NHA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA.md) - **Decision Date:** Apr 26, 2013 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 872.3630 - **Device Class:** Class 2 - **Review Panel:** Dental ## Intended Use Multi Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures. ## Device Story Multi Angled Abutment is a titanium alloy dental component; used to elevate restoration platforms when implant depth or angle precludes direct restoration. Device consists of an abutment and abutment screw; connects to HTIII SA Fixture system; used with non-hex Esthetic Cylinders. Operated by dental professionals in clinical settings; provides structural support for crowns, bridges, or overdentures. Benefits include improved prosthetic alignment and gingival shape; prevents screw hole exposure. Not for single-product use; not customizable. ## Clinical Evidence No clinical studies were submitted. Substantial equivalence is supported by bench testing, including biocompatibility assessments, risk analysis, and dimensional inspections. ## Technological Characteristics Material: Titanium alloy. Form factor: Multi-angled abutment with screw. Connection: Standardized abutment/implant interface. Dimensions: Various angles (17°, 30°) and diameters. Sterilization: Not specified. Software: None. ## Regulatory 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. ## Special Controls *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.) ## Predicate Devices - Prosthetic System ([K110308](/device/K110308.md)) ## Reference Devices - HTIII SA Fixture System ([K101096](/device/K101096.md)) - Esthetic Cylinders (K62030) ## Related Devices - [K081851](/device/K081851.md) — NEOSS ACCESS ABUTMENTS · Neoss, Ltd. · Mar 2, 2009 - [K111853](/device/K111853.md) — ANGLED TAPERED ABUTMENT · Zimmer Dental, Inc. · Dec 8, 2011 - [K232560](/device/K232560.md) — Angled Abutment · Arum Dentistry Co., Ltd. · Dec 19, 2023 - [K093643](/device/K093643.md) — MULTI- UNIT ABUTMENTS FOR STRAUMANN AND ASTRA TECH IMPLANT SYSTEMS · Nobel Biocare AB · Jun 24, 2010 - [K130662](/device/K130662.md) — ET PROSTHETIC SYSTEM · Osstem Implant Co., Ltd. · Jan 10, 2014 ## Submission Summary (Full Text) {0}------------------------------------------------ K12-3755 SSTEM Implant Co., Lt 507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea el: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com # 510(k) Summary APR 2 6 2013 This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: November 30, 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 Multi Angled Abutment Dental Abutment Abutment, implant, dental, endosseous 21CFR872.3630 Class II NHA - 3. Predicate Device : Prosthetic System, OSSTEM Implant Co., Ltd., K110308 #### 4. Description : The Multi Angled Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. . · The Multi Angled Abutment is used with Esthetic -low Cylinders (only Non-Hex) in the US System. K62030 and connected to HTIII SA Fixture in the HT3 SA Fixture System, K101096 1) The Multi Angled Abutment consists of Abutment and Abutment Screw. QS-Q1-505-3(Rev.0) Letter(8.5 X 11in) {1}------------------------------------------------ - 2) The Multi angle Abutment is used to elevate restoration platform when restoration to implant level is not practical due to depth or angle of implant for the edentulous patients in Anterior and Posterior, not customizable and can't be use a single product - 3) The Multi Angled Abutment is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. - 4) The Multi Angled Abutment is substantially equivalent in design, function and intended use to Prosthetic System (K110308) of OSSTEM Implant Co., Ltd., | | Multi Angled Abutment | Prosthetic System | |---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Osstem Implant Co., Ltd | Osstem Implant Co., Ltd | | 510(k) Number | New | K110308 | | Design | Image: Multi Angled Abutment design | Image: Prosthetic System design | | | Image: Multi Angled Abutment design details prevent exposure of the screw hole and form the natural gingival shape | Image: Prosthetic System design details | | Intended use | Multi Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. | Prosthetic System is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. | ## - Substantial Equivalence Matrix {2}------------------------------------------------ **OSSTEM** IMPLANT STEM Impla 07-8 Geoje3-Dong Yeonje-Gu Busan, 611 el: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.com | Dimension | | | |------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------| | A( $°$ ) | 17, 30 | 17, 30 | | B(mm) | 3.17, 3.4, 4.17, 4.4, 4.76, 4.86,<br>5.17, 5.4, 5.76, 5.86, 6.76, 6.86 | 5, 5.1, 5.5, 5.6, 6, 6.1, 6.5, 6.6, 7.5,<br>7.6 | | C( $Ø$ ) | 2.88, 3.43 | 2.84, 2.88, 3.39, 3.43 | | D( $Ø$ ) | 4.8 | 4.9 | | Connection | There is no modification to the abutment/implant connect has been made.<br>Therefore, There is no difference in connection part when compare with<br>predicate device(K110308) | | - 5. Indication for use : The Multi Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures. - 6. Review : The Multi Angled Abutment has similar material, indication for use, design and technological characteristics as the predicate device. #### 7. Summary of nonclinical testing Safety tests including biocompatibility have been considered to ensure the devices comply with the applicable international and US regulations as below. The Multi Angled Abutment is made of the same materials, manufacturing process, chemical composition, body contact with the predicate devices, Prosthetic System, OSSTEM Implant Co., Ltd., K110308 also, Risk analysis and dimension inspection were conducted - 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 QS-QI-505-3(Rev.0) Letter(8.5 X 11in) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "OSSTEM" in a stylized font. Below the word "OSSTEM" is the word "IMPLANT" in a smaller font. The letters are black and the background is white. There is a degree symbol after 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 on the information provided in this premarket notification Osstem Implant Co., Ltd. concludes that the Multi Angled Abutment is substantially equivalent to the predicate devices as .. described herein. QS-QI-505-3(Rev.0) {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a person with outstretched arms, composed of three curved lines. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 26, 2013 OSSTEM Implant Company, Limited C/O Mr. Patrick Lim HIOSSEN, Incorporated 85 Ben Fairless Drive FAIRLESS HILL PA-19030 Re: K123755 Trade/Device Name: Multi Angled Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: March 13, 2013 -Received: March 27, 2013 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. {5}------------------------------------------------ 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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/Resourcesfor You/Industry/default.htm. Sincerely yours, Image /page/5/Figure/8 description: The image shows a signature and a digitally signed statement. The signature reads "Susan Runner, DDSMA". The digitally signed statement indicates that the document was signed by Mary S. Runner-S on April 26, 2013, at 11:24:11 -04'00'. The statement also includes details such as DN, organizational units (HHS, FDA, People), and a numerical identifier. for 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 {6}------------------------------------------------ # OSSTEM Implant C OSSTEM® #507-8 Geoje3-Dong Yeonje-Gu Busan, 611-804 Republic of Korea Tel: +82 51 850-2500 Fax: +82 51 850-4341 www.osstem.co ## Indications for Use K123755 510(k) Number K Device Name : Multi Angled Abutment Indication for use : Multi Angled Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as bridges, or overdentures. Prescription Use_ ਮ (Per 21CFR801 Subpart D) OR Over-The-Counter Use (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) | | Digitally signed by Mary S. Runner | |--|------------------------------------| | | DN: c=US, o=U.S. Government, | | | ou=HHS, ou=FDA, ou=People, | | | cn=Mary S. Runner S, | | | 0.9.2342:19200300.100.1.1=13000 | | | 87950 | | | Date: 2013.04.26 11:21:11 -04'00' | (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices | 510(k) Number: | K123755 | |----------------|---------| |----------------|---------| QS-QI-505-2(Rev.0) Letter(8.5 X 1 im) . [ . --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K123755](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K123755) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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