ZIMMER DENTAL ONE-PIECE IMPLANT

K052997 · Zimmer Dental, Inc. · DZE · Jan 23, 2006 · Dental

Device Facts

• Record ID: K052997
• Device Name: ZIMMER DENTAL ONE-PIECE IMPLANT
• Applicant: Zimmer Dental, Inc.
• Product Code: DZE · Dental
• Decision Date: Jan 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Zimmer® One-Piece 3.7mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of partially edentulous jaws. Zimmer® One-Piece 3.7mm implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® 3.7mm One-Piece implant may be immediately restored with a temporary prosthesis that is not in functional occlusion. Zimmer® One-Piece 3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The Zimmer® One-Piece 3.0mm implant must be splinted if two or more are used adjacent to each other. The Zimmer® One-Piece 3.0mm implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

Device Story

Zimmer One-Piece Implant System is an endosseous dental implant combining implant and abutment sections into a single titanium alloy unit. Designed for surgical implantation into the jawbone to support dental prosthetics. Features pre-prepared, contoured abutment margins for esthetic restoration and a surface-treated, tapered implant body with double or triple-lead threads to enhance osseointegration. Used by dental professionals in clinical settings. The device provides a stable foundation for fixed single tooth or partial denture restorations. Clinical benefit includes simplified implantation and restoration process due to the integrated one-piece design.

Clinical Evidence

No clinical data. Substantial equivalence supported by mechanical testing.

Technological Characteristics

One-piece endosseous dental implant; material: titanium alloy; design: tapered body with double or triple-lead threads; surface treatment for osseointegration; pre-prepared contoured abutment margin.

Indications for Use

Indicated for support and retention of fixed single tooth and fixed partial denture restorations in partially edentulous jaws. 3.7mm implants for premolar, cuspid, and incisor regions; 3.0mm implants for mandibular central/lateral incisor and maxillary lateral incisor regions. Immediate loading permitted for 3.7mm in anterior mandibular arch if splinted with bar; temporary non-functional occlusion restoration permitted for both sizes.

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

• Zimmer Dental Inc., Screw-Vent® MTX ™ Selective Surface Implant (Cat. No. SVMB13)/ Zimmer Dental Hex-Lock™ Abutment (Cat. No. HLA3/3)
• Nobel Biocare Inc., NobelDirect™ 3.0 (Cat. No. 31456)

Submission Summary (Full Text)

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Zimmer Dental

1900 Aston Avenue

Carlsbad, CA 92008 760.929.4300 (ph)

760.431.7811 (fax)

510k No.: K052997

Page No.: A5-1

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

JA!、2 3 2006

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

- 1. Submitter's Information:

| Name: | Zimmer Dental Inc. |
|----------------|--------------------|
| Address: | 1900 Aston Ave. |
| | Carlsbad, CA 92008 |
| Phone: | 760-929-4300 |
| Contact: | Erin L. McVey |
| Date Prepared: | January 5, 2006 |

- 2. Device Name: Zimmer® One-Piece Implant System
Device Classification Name: Endosseous Dental Implant

- 3. Predicate Device(s):
Zimmer Dental Inc., Screw-Vent® MTX ™ Selective Surface Implant (Cat. No. SVMB13)/ Zimmer Dental Hex-Lock™ Abutment (Cat. No. HLA3/3)

Nobel Biocare Inc., NobelDirect™ 3.0 (Cat. No. 31456)

- 4. Device Description:
The Zimmer® Dental One-Piece Implant is a one-piece endosseous dental implant which is a combination of implant and abutment sections. The implant is composed of titanium alloy. The abutment portion is pre-prepared and contoured for esthetic restoration. The abutment portion of the implant features a pre-prepared margin to facilitate the restoration process. 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 either double or triple-lead threads, depending upon the apical diameter

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- 5. Intended Use:
Zimmer® One-Piece 3.7mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premol ar cuspit, and incisor regions of partially edentulous jaws. Zimmer® One-Piece 3.7mm implants may be loaded immediately in the anterior mandibular arch if our are splinted together with a bar. The Zimmer® 3.7mm One-Piece implant may be immediately restored with a temporary prosthesis that is not in fupctional occlusion.

Zimmer® One-Piece 3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of nartially edentulous jaws. The Zimmer® One-Piece 3.0mm implant must be splinted if two or more are used adjacent to each other. The Zimmer® One-Piece 3.0mm implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

- 6. Device Comparison:
The Zimmer® One-Piece implant is substantially equivalent to NobelDirect™ 3.0, as evidenced in mechanical testing. The Zimmer® One-Piece implant differs from the NobelDirect™ 3.0 implant with regard to certain features such as, pre-prepared, contoured abutment section, and implant thread pattern and shape. The Zimmer® One-Piece implant is substantially equivalent to the NobelDirect™3.0 implant in that it is manufactured from one piece of titanium with the abutment and implant portions combined. It is equivalent o the twopiece Zimmer Dental Screw-Vent®/Hex-Lock™ Abutment assembly in that it is manufactured from the same titanium alloy and has similar implant section design.

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Image /page/2/Picture/1 description: The image is a circular logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2006

Mr. Erin L. Mcvey Regulatory Affairs Specialist Zimmer Dental, Incorporated 1900 Aston Avenue Carlsbad, California 92008

Rc: K052997

Trade/Device Name: Zimmer® One-Piece Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: January 5, 2006 Received: January 6, 2006

Dear Mr. Mrvey:

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. Mevey

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 (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 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 Office of Compliance at [phone]. Ao, 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 Lin, 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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## Indications for Use

510(k) Number (if known):

Device Name: Zimmer® One-Piece Implant

Indications For Use:

Zimmer® One-Piece 3.7mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of partially edentulous jaws. Zimmer® One-Piece 3.7mm implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. The Zimmer® 3.7mm One-Piece implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

Zimmer® One-Piece 3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central and lateral incisor and maxillary lateral incisor regions of partially edentulous jaws. The Zimmer® One-Piece 3.0mm implant must be splinted if two or more are used adjacent to each other. The Zimmer® One-Piece 3.0mm implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Siren Roses

Katzman

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