TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620

K092403 · Zimmer Dental, Inc. · NHA · Oct 30, 2009 · Dental

Device Facts

• Record ID: K092403
• Device Name: TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620
• Applicant: Zimmer Dental, Inc.
• Product Code: NHA · Dental
• Decision Date: Oct 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Ti Prepable Abutments are designed for use as a terminal or intermediate abutment for cement retained prostheses. It allows for preparation for the crown to be attached. It can be used for a single or multiple-unit restoration. The abutment is intended to be prepared and placed with patient specific margins.

Device Story

Ti Prepable Abutment is a titanium alloy post used in dental implant systems; functions as terminal or intermediate abutment for cement-retained prostheses. Device features unprepared shape allowing clinician or dental laboratory to remove material from cone and margin areas to create natural prosthetic attachment. Spline tines provide anti-rotation; secured to implant via retaining screw. Used by dental clinicians or laboratories to support single or multiple-unit restorations. Benefits patient by enabling customized prosthetic margins for crown attachment.

Clinical Evidence

Bench testing only; mechanical fatigue testing performed to validate the assembly strength with the modified retaining screw.

Technological Characteristics

Titanium alloy post; Spline implant/abutment interface; mechanical fixation via retaining screw; unprepared geometry for custom clinical/laboratory preparation.

Indications for Use

Indicated for use as a terminal or intermediate abutment for cement-retained single or multiple-unit dental prostheses, requiring clinician preparation for patient-specific margins.

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

• Integral VII 3.25mm Biointegrated Dental Implant System (Fixed Abutment) (1506, 1507, 1508, and 1510)

Submission Summary (Full Text)

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Zimmer Dental

510k No.: K092463

1900 Aston Avenue Carlsbad, CA 92008 760.929.4300 (ph) 760.431.7811 (fax)

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# Traditional 510(k) PRE-MARKET NOTIFICATION 510(k)

## OCT 3 0 2009

## 510(k) SUMMARY (21CFR807.92(a))

- Submitter's Information: 1.
Zimmer Dental Inc. Name:

1900 Aston Ave. Address: Carlsbad, CA 92008

760-929-4300 Phone:

Larissa D'Andrea McMullin Contact:

Date Prepared: October 23, 2009

- Ti Prepable Abutment 2. Device Name: (cat no. 1618, 1619, 1620)
Device Classification Name: Endosseous Dental Implant

Predicate Device(s): Integral VII 3.25mm Biointegrated Dental Implant System 3. (Fixed Abutment) (1506, 1507, 1508, and 1510)

- Device Description: র্ব .
The Prepable Abutment is a titanium alloy post with an unprepared shape that allows for preparation by the end user. The spline tines on the inside of the abutment provide an anti-rotation feature and the abutment is secured with a separate retaining screw.

- 5. Intended Use:
The Ti Prepable Abutments are designed for use as a terminal or intermediate abutment for cement retained prostheses. It allows for preparation for the crown to be attached. It can be used for a single or multiple-unit restoration. The abutment is intended to be prepared and placed with patient specific margins.

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#### Device Comparison: 6.

The new device is substantially equivalent to the predicate. The devices, general structure, and function in the endosseous implant system remains the same as the predicate devices. It is fabricated from the same titanium alloy as the predicates and utilizes a Spline implant/abutment interface which is identical in size and shape (for a given platform diameter) to the predicate device. The new device will be affixed to the implant by a retaining screw, the same manner as the predicate; however, the retaining screw utilized is different then that used by the predicate. Mechanical fatigue testing has demonstrated that the change in retaining screw does not adversely affect the mechanical strength of the implant/abutment assembly.

Typically abutments are prepared for use by the clinician or a dental laboratory by removing material from the cone and margin areas. The new abutment differs from the predicate by providing more material that the dental clinician or a dental laboratory can utilize to create a natural prosthetic attachment.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Ms. Larissa D'Andrea McMullin Associate Manager, Regulatory Affairs Zimmer Dental Incorporated 1900 Aston Avenue Carlsbad, California 92008

## OCT 3 0 2009

Re: K092403

> Trade/Device Name: Ti Prepable Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 1, 2009 Received: August 6, 2009

Dear Ms. McMullin:

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.

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. McMullin

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/cdrh/industry/support/index.html.

Sincerely yours,

for

Susan Runner, D.D.S., M.A Acting 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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Ti Prepable Abutment Zimmer Dental

## Indications for Use

510(k) Number (if known):

Device Name: Ti Prepable Abutment

Indications For Use:

The Ti Prepable Abutments are designed for use as a terminal or intermediate abutment for cement retained prostheses. It allows for preparation for the crown to be attached. It can be used for a single or multiple-unit restoration. The abutment is intended to be prepared and placed with patient specific margins.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Mulvey for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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Page: Section A4-1

510(k) Number: K092403