17 ANGULATED ABUTMENT

K961736 · Nobelpharma USA, Inc. · NHA · Jul 18, 1996 · Dental

Device Facts

• Record ID: K961736
• Device Name: 17 ANGULATED ABUTMENT
• Applicant: Nobelpharma USA, Inc.
• Product Code: NHA · Dental
• Decision Date: Jul 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Indications for Use

Indicated for edentulous patients requiring an anchor to support a dental prosthesis.

Regulatory Classification

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)

Submission Summary (Full Text)

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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 [phone]. 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.

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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.

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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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,


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

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(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)