REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162

K020646 · Nobel Biocare Uas, Inc. · DZE · May 29, 2002 · Dental

Device Facts

• Record ID: K020646
• Device Name: REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162
• Applicant: Nobel Biocare Uas, Inc.
• Product Code: DZE · Dental
• Decision Date: May 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Replace HA Coated Implants is for restoring chewing function by serving as anchorage for dental restorations.

Device Story

Replace HA Coated Implant serves as anchorage for dental restorations to restore chewing function. Device consists of titanium alloy root-form implant with hydroxyapatite (HA) coating on root portion. Available in diameters 3.5mm, 4.3mm, 5.0mm, 6.0mm and lengths 10mm, 13mm, 16mm. Used by dental surgeons in clinical settings for single or two-stage procedures. Implant provides structural support for prosthetic devices; immediate placement and function indicated for type I or II bone. Benefits include restoration of masticatory function.

Clinical Evidence

Clinical results provided to support the safety and effectiveness of the expanded indications for use. No specific sample sizes or statistical metrics provided in the summary.

Technological Characteristics

Titanium alloy endosseous dental implant with hydroxyapatite (HA) coating on root form portion. Available in multiple diameters (3.5-6.0 mm) and lengths (10-16 mm). No design modifications made to the device itself.

Indications for Use

Indicated for single-stage or two-stage surgical procedures and cement or screw retained restorations. Intended for immediate placement and function on single or multiple tooth applications in good quality bone (type I or type II) to restore chewing function.

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

• Replace™ HA Coated Implant (K962845)
• Steri-Oss 3.25 mm Replace™ HA Coated Implant (K973423)

Submission Summary (Full Text)

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K020646

# Nobel Biocare

# 510(k) Summary

| Establishment<br>Information | Nobel Biocare USA, Inc.<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887<br>USA |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: [phone], ext 5074<br>Fax: [phone] |
| Contact | Vincent Cheung<br>Manager, Regulatory Affairs & Quality Assurance<br>[phone] |
| Proprietary<br>device name | Replace™ HA Coated Implant (K962845)<br>Steri-Oss 3.25 mm Replace™ HA Coated Implant (K973423) |
| Classification<br>name | Endosseous Dental Implant (21 CFR 872.3640) |
| Device<br>classification | Class III |
| Statement | The information supporting claims of substantial equivalence, as<br>defined under the Federal Food, Drug, and Cosmetic Act, respecting<br>safety and effectiveness is summarized below. |
| Device<br>description | The Replace ™ HA Coated Implant is to serve as a support for<br>prosthetic devices to restore a patient's chewing function. The<br>available diameters are 3.5 mm, 4.3 mm, 5.0 mm and 6.0 mm with<br>lengths of 10 mm, 13 mm, and 16 mm. The titanium alloy implant<br>has an HA coating on the root form portion to within approximately 2<br>mm of the top. |
| Intended use | The intended use of the Replace HA Coated Implants is for restoring<br>chewing function by serving as anchorage for dental restorations. |

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Nobel Biocare USA, Inc.

22715 Savi Runch Parkway, Yorba Linda, CA 92887
Telephone [phone])
Fax [phone])
Fax [phone]

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| Indications for use | The Replace HA Coated Implant is both for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Replace HA Coated Implant is intended for immediate placement and function on single tooth and/or multiple tooth applications in good quality bone (type I or type II bone), to restore chewing function. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological characteristics | The technological characteristics of the Replace HA Coated Implants remained unchanged. No design modification was made. |
| Performance data | Clinical results show that the expanded Indications for Use is as safe and effective as the original Indications for Use. |
| Conclusion | Based on the 510(k) summaries, 510(k) statements and the information provided herein, we conclude that the expanded Indications for Use is substantially equivalent to the currently marketed device under the Federal Food, Drug, and Cosmetic Act. |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 2 9 2002

Mr. Vincent Cheung Manager, Regulatory Affairs & Quality Assurance Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K020646

Trade/Device Name: Replace HA Coated Implant Models, 35102, 35132, 35162, 43132, 43162 Regulation Number: 876.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: February 26, 2002 Received: February 28, 2002

Dear Mr. Cheung:

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 (1 wr 1), it has ob adjoor 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.

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.

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### Page 2 - Mr. Cheung

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 and instills (21 set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet form in order 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 110(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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). Other general information on your 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number (if known): K020646 Replace™ HA Coated Implant Device Name:

Indications for Use:

The Replace™ HA Coated Implant is for single-stage or two-stage surgical procedures The Replace TIA Coated migrations. The Replace HA Coated Implant is intended and centent of Screw relation on single tooth and/or multiple tooth applications
for immediate placement and function on single tooth and/or multiple tooth applications in good quality bone (type I or type II bone), to restore chewing function.

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Concurrence of CDRH, Office of Device Evaluation (ODE) . -Over-the-Counter Use OR Prescription Use Optional Format 1-2-96 (per 21 CFR 801.109) Justan (Division Sign-Off) (Division Sign-Ont)
Division of Dental, Infection Control, Division of Dospital Devices 102010 510(k) Number -