ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315

K052885 · Nobel Biocare USA, LLC · NHA · Dec 23, 2005 · Dental

Device Facts

• Record ID: K052885
• Device Name: ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315
• Applicant: Nobel Biocare USA, LLC
• Product Code: NHA · Dental
• Decision Date: Dec 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic component directly on the Zygoma implant and is intended for use as an aid in prosthetic rehabilitation.

Device Story

Zygoma Angled Abutment serves as prosthetic interface for Nobel Biocare Zygoma implants; facilitates prosthetic rehabilitation. Device functions as mechanical connector between implant and dental prosthesis. Used in clinical dental settings by trained dental professionals. Output is physical support structure for dental restoration; enables functional tooth replacement for patients with specific anatomical requirements necessitating zygomatic anchorage.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endosseous dental implant abutment; Class II device (21 CFR 872.3630). Mechanical prosthetic component designed for attachment to Zygoma implants. No software, electronics, or energy sources involved.

Indications for Use

Indicated for use as a prosthetic component on Zygoma implants to aid in prosthetic rehabilitation for patients requiring dental implant support.

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

• Branemark System 17° Angulated Abutment (K944962)

Submission Summary (Full Text)

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## DEC 2 3 2005

## 510(k) Summary of Safety and Effectiveness 1.4

| Submitted by: | Herbert Crane<br>Director, Regulatory Affairs |
|----------------------------------------|----------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Date of Submission: | November 23, 2005 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietary<br>or Model Name: | Zygoma Angled Abutments |
| Legally Marketed Devices: | Branemark System 17° Angulated Abutment (K944962) |

## Device Description:

Device Description.
The Zygoma Angled Abutment is an artificial tooth abutment designed to fit and function on Nobel Biocare's Zygoma implant.

The Zygoma Angled Abutment is intended to be used as a prosthetic component directly The Zygonia Angled Abdamont is intended for use as an aid in prosthetic rehabilitation.

Indications for Use:

inglications for USE.
The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prostherity in The Nobel Blocare Zygoma Angled Koathent is intended for use as an aid in prosthetic rehabilitation.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 3 2005

Mr. Herbert Crane Regulatory Affairs Director Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K052885

Trade/Device Name: Zygoma Angled Abutments Regulation Number: 872.3630 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: NHA Dated: October 12, 2005 Received: October 20, 2005

Dear Mr. Crane:

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 mensiale commerce prior to may 20, 20, 20, 20, 20, 2011 accordance with the provisions of / Innenthelia, of to arrand Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvial applisions 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 such additional controls. Existing major regulations affecting (1 Writ), it may of bacyoo in the Code of Federal Regulations, Title 21. Parts 800 to 898. In your device ear. be fourther announcements concerning your device in the Federal Register.

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Page 2 -Mr. Crane

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 Incall that I Dri has made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal bated is requirements, including, but not limited to: registration 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 et read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set fortal in the qualify is a control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow your be objection of substantial equivalence of your device to a premarket notification. - The Pie results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at no at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other generational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sutte y. Michael Oms.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K052885

Device Name: Zygoma Angled Abutments

Indications For Use:

indications I or 530.
The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic The Nobol Elocal o Eygoniant and is intended for use as an aid in prosthetic rehabilitation.

× 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)

Kein Moley for MSR

K052885

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