PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S

K092377 · Zimmer Dental, Inc. · NHA · Nov 3, 2009 · Dental

Device Facts

• Record ID: K092377
• Device Name: PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S
• Applicant: Zimmer Dental, Inc.
• Product Code: NHA · Dental
• Decision Date: Nov 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The Plastic Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The Plastic Temporary Abutment can be used for cement-retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Plastic Temporary Abutment is not to exceed one-hundred and eighty (180) days.

Device Story

Plastic Temporary Abutment; endosseous dental implant abutment. Fabricates/supports provisional restorations; aids in creating esthetic gingival emergence during healing period. Used for cement-retained or screw-retained, single-unit or multi-unit restorations. Placed by dental professionals in clinical settings. Material: PEEK CLASSIX. Available in straight/angled versions; interfaces with Tapered Screw-Vent Implants; 1mm or 4mm cuff heights. Single-use; duration limit 180 days.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Material: PEEK CLASSIX. Form factor: Straight and angled abutments with 1mm or 4mm cuff heights. Interface: Tapered Screw-Vent Implant compatible. Single-use. No energy source or software.

Indications for Use

Indicated for patients requiring provisional dental restorations during the healing period prior to final restoration. Supports single-unit and multi-unit cement-retained or screw-retained provisional restorations for up to 180 days.

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

• Hex-Lock® Temporary Abutment
• Friadent® EsthetiCap
• PreFormance Post

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for Zimmer Dental. The logo consists of a circle with a stylized "Z" inside, above the word "zimmer" in a serif font. Below "zimmer" is the word "dental" in a sans-serif font.

| Zimmer Dental |
|---------------|
|---------------|

K092377 510k No.:

A5-1 Page No.:

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

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

NOV - 3 2009

# 510(k) SUMMARY (21CFR 807.92(a))

- 1. Submitter's Information:

| Name: | Zimmer Dental Inc. |
|----------------|---------------------------------------|
| Address: | 1900 Aston Ave.<br>Carlsbad, CA 92008 |
| Phone: | 760-929-4300 |
| Contact: | William Fisher |
| Date Prepared: | November 3, 2009 |

- 2. Plastic Temporary Abutment Device Name: Device Classification Name: Endosseous Dental Implant Abutment Device Regulation Number : 872.3630 Product Code : NHA, Dental
- Hex-Lock® Temporary Abutment 3. Predicate Device(s): Friadent® EsthetiCap PreFormance Post

### Device Description: 4.

The Plastic Temporary Abutments are endosseous dental implant abutments that are designed for single use as a temporary prosthesis during the healing process while the permanent prosthesis is fabricated. The PEEK CLASSIX material, when utilized as a Temporary Abutment, can be placed in use for up to 180 days. They are available in straight and angled versions, with interfaces to match the three diameters of Tapered Screw-Vent Implants, and 1mm or 4mm cuff height options.

### Indications for Use: 5.

The Plastic Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The Plastic Temporary Abutment can be used for cement-retained or screw-retained provisional restoration. The

{1}------------------------------------------------

510(k) No. A5-2 Page No. __

abutments can be used for single-unit and multi-unit restorations. Use of the Plastic Temporary Abutment is not to exceed one-hundred and eighty (180) days.

#### 6. Device Comparison:

The Plastic Temporary Abutment is substantially equivalent to the original Hex-Lock® Temporary Abutment by design. They are substantially equivalent to the Friadent® EsthetiCap in that the materials and intended use are similar for both products. The Plastic Temporary Abutment is substantially equivalent to the PreFormance Post in that the body of the products are the same material as well as the intended use and period of use are equivalent.

{2}------------------------------------------------

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 stylized human figure with outstretched arms, representing care and protection. The figure is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

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

Mr. William Fisher Regulatory Affairs Associate Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008-7308

NOV - 3 2009

Re: K092377

Trade/Device Name: Plastic Temporary Abutment Regulation Number: 21CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: August 3, 2009 Received: August 5, 2009

Dear Mr. Fisher:

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.

{3}------------------------------------------------

## Page 2- Mr. Fisher

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Rumsey

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

{4}------------------------------------------------

510(k) No. Zimmer Dental Plastic Temporary Abutment

No. K092377

A4 Page 1 of 1

# Indications for Use

510(k) Number (if known):

Plastic Temporary Abutment Device Name:

Indications For Use:

The Plastic Temporary Abutment is intended to be used to fabricate and support provisional restorations that aid in creating an esthetic emergence through the gingiva during the healing period and prior to final restoration. The Plastic Temporary Abutment can be used for cementretained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Plastic Temporary Abutment is not to exceed onehundred and eighty (180) days.

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)

Keri Mulry for HSR

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

510(k) Number: K092377

Page 1 of 1

Page: Section A4-1