ZYGOMA TIUNITE

K050641 · Nobel Biocare USA, LLC · NHA · Apr 7, 2005 · Dental

Device Facts

• Record ID: K050641
• Device Name: ZYGOMA TIUNITE
• Applicant: Nobel Biocare USA, LLC
• Product Code: NHA · Dental
• Decision Date: Apr 7, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nobel Biocare's Zygoma TiUnite® is a titanium, endosseous implant with components intended to be placed in the upper jaw and provide support for prosthetic devices such as artificial teeth in order to restore patient esthetics and chewing function. Nobel Biocare's Zygoma TiUnite® includes endosseous implants, a cover screw, healing abutments, and multi-unit abutments.

Device Story

Zygoma TiUnite is a titanium endosseous dental implant system; includes implants, cover screws, healing abutments, and multi-unit abutments. Placed in the upper jaw (zygomatic region) by dental surgeons to provide anchorage for prosthetic teeth. Restores patient esthetics and masticatory function. Device functions as a mechanical anchor for dental prosthetics; no electronic or software components.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Titanium endosseous dental implant system. Includes implants, cover screws, healing abutments, and multi-unit abutments. Mechanical fixation device. No energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring dental restoration in the upper jaw; provides support for prosthetic devices (artificial teeth) to restore esthetics and chewing function.

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.)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ОСТ 4 2010

Nobel Biocare USA, LLC C/O Ms. Phuong Nguyen Son 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K050641

Trade/Device Name: Zygoma TiUnite Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA 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.

h for

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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## Indications for Use

KOSO641

510(k) Number (if known):

Device Name: Zygoma TiUnite®

Indications For Use:

lulcations For OGS:
Nobel Biocare's Zygoma TiUnite® is a titanium, endosseous implant with components Nobel Biocare's Zygoma Trumler (s a manilar), crowide support for prosthetic devices such
intended to be placed in the upper jaw in the stime and chawing function intended to be placed in the upper job and chewing function.
as artificial teeth in order to restore patient esthetics and chewing function.

Nobel Biocare's Zygoma TiUnite® includes endosseous implants, a cover screw, healing abutments, and multi-unit abutments.

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

Citiston Sign-Off) Wision of Anesthesiology, General Hospital, Intection Control, Dental Devices

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