← Product Code [NHA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA) · K961736 # 17 ANGULATED ABUTMENT (K961736) _Nobelpharma USA, Inc. · NHA · Jul 18, 1996 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K961736 ## Device Facts - **Applicant:** Nobelpharma USA, Inc. - **Product Code:** [NHA](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA.md) - **Decision Date:** Jul 18, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3630 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use The Nobelpharma 17° Angulated Abutment is intended to be used in edentulous patients as an anchor to support a prosthesis. ## Device Story The 17° Angulated Abutment is a dental implant component used to support prosthetic devices and restore chewing function. It attaches to an endosseous implant fixture. The device features a modified, narrowed base and external diameter, along with narrowed abutment screws, to accommodate smaller diameter fixtures. It is used by dental professionals in a clinical setting to provide a stable anchor for prosthetics in edentulous patients. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Endosseous dental implant abutment. Dimensional modification (narrowed base/diameter) to fit smaller diameter fixtures. Mechanical connection to endosseous implant. ## 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 - 17° Angulated Abutment ([K944962](/device/K944962.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K961736 JUL 18 1996 Pre-Market Notification May 1, 1996 Page 2 ## VI. 510(k) Summary of Safety and Effectiveness ### A. Name and Address This Summary of Safety and Effectiveness is being submitted by Nobelpharma USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, IL 60559. Their telephone number is (708) 654-9100. The contact person will be the Director, Regulatory Affairs. This summary was prepared on May 1, 1996. ### B. Name of the Device This device is generally known as an abutment to an endosseous implant with the trade name BRÅNEMARK SYSTEM® 17° Angulated Abutment. This submission is a modification to an previously cleared device subject to K944962. ### C. The Predicate Product The predicate product used in this Premarket Notification is the previous version of the same device, 17° Angulated Abutment, K944962. ### D. Description of the Device The Nobelpharma 17° Angulated Abutment is an abutment used with an endosseous implant. The abutment sits upon the implanted fixture and is used to support prosthetic devices and restore chewing functions in edentulous patients. The only modification is the narrowing of the base and external diameter of the abutment; and narrowing of the diameters of the abutment screws, adding one series of abutments to fit the smaller diameter fixtures previously cleared. ### E. Intended Use of the Device The Nobelpharma 17° Angulated Abutment is intended to be used in edentulous patients as an anchor to support a prosthesis. ### F. Comparison of Technological Characteristics The technological characteristics between the modified version of the 17° Angulated Abutment and the earlier version are identical. The changes are minor dimensional changes to the diameter of the abutment and abutment screw. {1} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room –WO66-G609 Silver Spring, MD 20993-0002 SEP 17 2010 Ms. Phuong Nguyen Son Regulatory Affairs Manager Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887 Re: K961736 Trade/Device Name: 17" Angulated Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHZ Dated: July 28, 2010 Received: July 29, 2010 Dear Ms. Nguyen Son: This letter corrects our substantially equivalent letter of July 28, 2010. 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 (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. 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. {2} Page 2- Ms. Nguyen Son 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 yours, ![img-0.jpeg](img-0.jpeg) Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and dental Devices Office of Device Evaluation Center for Devices and Radiological Health {3} (b) Number (if known): K961736 Device Name: 17° Angulated Abutment Indications For Use: Intended to be used in edentulous patients as an anchor to support a prosthesis. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Susan Oursner Division of Dental, Infection Control, and General Hospital Dept. 510(k) Number 10101731 Prohibition Use ☐ Per 21 CFR 801.109 OR Over-The-Counter Use ☐ (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K961736](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/NHA/K961736) **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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