REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE

K023952 · Nobel Biocare Uas, Inc. · DZE · Jan 16, 2003 · Dental

Device Facts

• Record ID: K023952
• Device Name: REPLACE ONE PIECE IMPLANT, HA, REPLACE ONE PIECE IMPLANT, TIUNITE
• Applicant: Nobel Biocare Uas, Inc.
• Product Code: DZE · Dental
• Decision Date: Jan 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Replace® One Piece Implant is a threaded one-piece implant with an integrated abutment, designed for single-stage surgical procedure and cemented restorations. The Replace One Piece Implant is intended for immediate load on single tooth and multiple tooth applications in good quality bone, to restore chewing function.

Device Story

Replace One Piece Implant; threaded root-form dental implant with integrated abutment; eliminates separate abutment attachment step. Manufactured from CP4 Titanium; available with TiUnite or HA coating. Diameters 3.5, 4.3, 5.0mm; lengths 10, 13, 16mm. Acid-etched transmucosal/transgingival neck promotes connective tissue attachment. Used by dental surgeons in clinical settings for immediate load applications. Device provides structural foundation for cemented dental restorations; restores patient chewing function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

One-piece threaded root-form dental implant; CP4 Titanium construction; TiUnite or HA surface coatings; acid-etched neck. Diameters: 3.5, 4.3, 5.0mm; Lengths: 10, 13, 16mm. Mechanical fixation via osseointegration.

Indications for Use

Indicated for partially edentulous patients requiring single or multiple tooth replacement in good quality bone to restore chewing function via immediate load, single-stage surgical procedure, and cemented restorations.

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.

Reference Devices

• Nobel Biocare Replace implant

Submission Summary (Full Text)

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K023952

## 510(K) SUMMARY ડ.

JAN 16 2003

| Establishment | Nobel Biocare USA, Inc.<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
|----------------------------|----------------------------------------------------------------------------------|
| | Phone: [phone] |
| | Fax: [phone] |
| Contact | Kathleen Dragovich<br>Regulatory Affairs Specialist<br>[phone], ext. 7834 |
| Proprietary<br>Device Name | Replace® One Piece Implant |
| Classification<br>Name | Endosseous Dental Implant (21 CFR 872.3640) |
| Device<br>Classification | Class III |

## Device Description

The Replace One Piece Implant is a one-piece, threaded root-form implant based on the Nobel Biocare Replace implant design. The new configuration of the implant is designed with an integrated abutment that will eliminate the step of attaching the abutment.

This combination of design characteristics also includes acid etching of the transmucosal/transgingival neck to encourage connective tissue attachment for esthetics purposes. The device is manufactured of CP4 Titanium and is offered in TiUnite and HA Coating. This device will be offered in diameters of 3.5. 4.3. and 5.0mm, each in lengths of 10, 13, and 16mm.

This implant is designed for immediate load applications in partially edentulous patients.

## Indications for Use

The Replace® One Piece Implant is a threaded one-piece implant with an integrated abutment, designed for single-stage surgical procedure and cemented restorations. The Replace® One Piece Implant is intended for immediate load on single tooth and multiple tooth applications in good quality bone, to restore chewing function.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three curved lines. The figure is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

-Ms. Kathleen Dragovich Regulatory Affairs Specialist Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887

JAN 16 2003

Re: K023952

Trade/Device Name: Replace® One Piece Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: November 26, 2002 Received: November 27, 2002

Dear Ms. Dragovich:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 - Ms. Dragovich

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 Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, 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 vour responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Timothy Ulatowski

Timo A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## INDICATIONS FOR USE STATEMENT 8.

K023952

Page 1 of 1

510(k) Number (if known):

Not yet assigned

Device Name: Indications for Use: Replace® One Piece Implant

The Replace® One Piece Implant is a threaded one-piece implant with an integrated abutment, designed for single-stage surgical procedure and cemented restorations. The Replace One Piece Implant is intended for immediate load on single tooth and multiple tooth applications in good quality bone, to restore chewing function.

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

Prescription Use V (per 21 CFR 801.109) OR

Over-the-Counter Use Optional Format 1-2-96

Susan Rumpo

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices rod 510(k) Number.

Nobel Biocare USA, Inc. Replace One Piece Implant November 2002