TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16

K072589 · Zimmer Dental, Inc. · DZE · Oct 4, 2007 · Dental

Device Facts

• Record ID: K072589
• Device Name: TAPERED SCREW-VENT IMPLANT, 4.1MM, MODELS: TSV4B8, B10, B11, B13 AND B16, TSV4H8, H11, H13 AND H16
• Applicant: Zimmer Dental, Inc.
• Product Code: DZE · Dental
• Decision Date: Oct 4, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tapered Screw-Vent 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 Screw-Vent Implant, 4.1mm, is an endosseous dental implant used by dental professionals to replace missing teeth. The device is surgically placed into the maxilla or mandible. It features a tapered design with double-lead threads and a surface treatment to facilitate osseointegration. The implant provides a foundation for prosthetic tooth replacement. It is intended for either immediate loading or delayed loading following a conventional healing period, provided primary stability is achieved. The device is a dimensional modification of existing predicate implants.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endosseous dental implant composed of titanium alloy. Features a tapered body design with double-lead threads and a surface treatment for osseointegration. 4.1mm diameter. Mechanical device; no software or energy source.

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 Screw-Vent Implant, 3.7mm (K013227, K061410)

Submission Summary (Full Text)

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

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

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K072589

## Special 510(k): Device Modification RE-MARKET NOTIFICATION 510(k)

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

- 1. Submitter's Information:
2007 007 4

| Name: | Zimmer Dental Inc. |
|----------------|--------------------|
| Address: | 1900 Aston Ave. |
| | Carlsbad, CA 92008 |
| Phone: | 760-929-4300 |
| Contact: | William Fisher |
| Date Prepared: | September 13, 2007 |

- 2. Device Name: Tapered Screw-Vent Implant, 4.1mm (cat no. TSV4B8, TSV4B10, TSV4B11, TSV4B13, TSV4B16, TSV4H8, TSV4H10, TSV4H11, TSV4H13, TSV4H16)
Device Classification Name: Endosseous Dental Implant

3. Predicate Device(s): Tapered Screw-Vent Implant, 3.7mm (cat. no. TSVB8, TSVB10. TSVB11. TSVB13. TSVB16. TSVH8, TSVH10, TSVH11, TSVH13, TSVH16)

#### 4. Device Description:

The Tapered Screw-Vent Implant, 4.1mm is an endosseous dental implant. The implant is composed of titanium alloy. The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. In addition, the implant section is tapered with double-lead threads.

- 5. Intended Use:
The Tapered Screw-Vent 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.

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K012589

Tapered Screw-Vent Implant, 4.1mm; 510(k) Summary cont'd:

### 6. Device Comparison:

The new device is equivalent in design with Predicate. The new device is a dimensional modification to the Predicate cleared in K013227, K061410. It differs from the Predicate in that the body portion of the new device is 4.1mmD. The materials, general structure, and function in the endosseous implant system remains the same as the Predicate Device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" surrounding a stylized emblem. The emblem features three parallel lines that curve upwards and to the right, resembling a bird in flight or a stylized representation of human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

OCT 4 * 2007

Re: K072589

Trade/Device Name: Tapered Screw-Vent Implant, 4.1mmD Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 13, 2007 Received: September 14, 2007

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 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 (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.

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 vour 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 Office of Compliance 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 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,

Chiu-Yueh, Ph.D.

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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K0n2589

12.7

## Indications for Use

NO KE 510(k) Number (if known):

Device Name: Tapered Screw-Vent Implant, 4.1mmD

Indications For Use:

The Tapered Screw-Vent 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 (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)

Sver Ruaser

Sion Sign-Off) Covision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K072586