ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS

K082639 · Zimmer Dental, Inc. · DZE · Dec 19, 2008 · Dental

Device Facts

• Record ID: K082639
• Device Name: ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS
• Applicant: Zimmer Dental, Inc.
• Product Code: DZE · Dental
• Decision Date: Dec 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Tapered SwissPlus® Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

Device Story

Tapered SwissPlus® Implant is an endosseous dental implant for single-stage placement in maxilla or mandible. Device consists of pure titanium or titanium alloy; features tapered design with double-lead threads. Surface options include hydroxylapatite (HA) coating, HA coating with MP-1® processing, or MTX surface. Implant is surgically placed by dental professionals to replace missing teeth; supports immediate or delayed loading protocols. Benefits include restoration of dental function and aesthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endosseous dental implant; materials: pure titanium or titanium alloy; surface treatments: hydroxylapatite (HA) coating, MP-1® processing, or MTX surface; design: tapered with double-lead threads; intended for single-stage placement.

Indications for Use

Indicated for patients requiring replacement of one or more missing teeth in the maxilla or mandible. Suitable for immediate loading given good primary stability and appropriate occlusal load, or for loading after conventional healing.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• Tapered SwissPlus®, MTX Surface Implant (K082639)
• Tapered Screw-Vent®, MP-1® HA Coated Implant (K082639)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for Zimmer Dental. The logo features a stylized letter "Z" inside of a circle. Below the circle, the word "zimmer" is written in a bold, sans-serif font, and the word "dental" is written in a smaller, non-bold font.

Zimmer Dental

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

510k No.: K082639

ge No.: A5-1

DEC 1 9 2008

## Traditional 510(k) PRE-MARKET NOTIFICATION

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

- Submitter's Information: 1.

| Name: | Zimmer Dental Inc. |
|----------------|-------------------------|
| Address: | 1900 Aston Ave. |
| | Carlsbad, CA 92008-7308 |
| Phone: | 760-929-4300 |
| Contact: | William Fisher |
| Date Prepared: | August 21, 2008 |

- Device Name: Tapered SwissPlus® Implant 2.
Device Classification Name: Endosseous Dental Implant

- Predicate Device: Tapered SwissPlus®, MTX Surface Implant 3. Tapered Screw-Vent®, MP-1® HA Coated Implant
- 4. Device Description:

The Tapered SwissPlus® implant is an endosseous dental implant designed for single stage placement. The implant is composed of pure titanium or titanium allov. The implant is tapered with double-lead threads. The new device will feature hydroxylapatite coating, hydroxylapatite coating with additional Zimmer Dental MP-1® processing, or MTX surface equivalent to existing Zimmer Dental implants.

- 5. Intended Use:
The Tapered SwissPlus® Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

- 6. Device Comparison:
The new device is substantially equivalent to Tapered SwissPlus MTX Implant, in that it is manufactured to the same implant and interface design. The new device is substantially equivalent to the Tapered Screw-Vent Implant in that it is manufactured of, and coated with the same materials utilizing equivalent processes.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2008

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

Re: K082639

> Trade/Device Name: Tapered SwissPlus® Implant Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 29, 2008 Received: September 23, 2008

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 such 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 - 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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), 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Susan Kuores
Sachiko S. Liem, Ph.D.

Chiu S. Lin, Ph. D Division 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):

K082639

Tapered SwissPlus® Implant Device Name:

Indications For Use:

The Tapered SwissPlus® Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

Prescription Use X (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)

Susan Purve

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

510(k) Number: K020

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