NOBELREPLACE ADAPTER, MODEL 32412

K050444 · Nobel Biocare Uas, Inc. · NHA · Jul 7, 2005 · Dental

Device Facts

• Record ID: K050444
• Device Name: NOBELREPLACE ADAPTER, MODEL 32412
• Applicant: Nobel Biocare Uas, Inc.
• Product Code: NHA · Dental
• Decision Date: Jul 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nobel Biocare's NOBELREPLACE® Adapter is a bushing that enables seating of a smaller diameter abutment to a larger diameter endosseous implant-supported dental restoration of a partially or fully edentulous jaw in order to restore patient esthetics and chewing function.

Device Story

NOBELREPLACE® Adapter is a hollow titanium alloy bushing; functions as an accessory component within an implant/abutment system. Device adapts smaller platform abutments to larger platform endosseous implants; provides gradual transition between components. Used in dental clinics by dentists/specialists; remains in patient's mouth as a permanent component of the restoration. Benefits include enabling compatibility between different implant/abutment sizes, facilitating restoration of chewing function and esthetics in edentulous or partially edentulous patients.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Material: Titanium vanadium alloy. Form factor: Hollow bushing. Function: Load-bearing adapter for implant/abutment systems. Sterility: Sterile. Connectivity: None (mechanical component).

Indications for Use

Indicated for partially or fully edentulous patients requiring dental restoration to restore esthetics and chewing function; enables seating of smaller diameter abutments onto larger diameter endosseous implants.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). 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.)

Predicate Devices

• Replace Scalloped Margin Implant System (K021584)
• Nobel Biocare Permanent Centric Post (K040573)

Submission Summary (Full Text)

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Koso444

JUL 7 - 2005

### 510(k) Summary of Safety and Effectiveness 1.4

| Submitted by: | Elizabeth J. Mason<br>Sr. Regulatory Affairs Specialist |
|----------------------------------------|-----------------------------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 7830 |
| Facsimile: | [phone] |
| Date of Submission: | February 18, 2005 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietary<br>or Model Name: | NOBELREPLACE® Adapter |
| Legally Marketed Device(s): | Replace Scalloped Margin Implant System (K021584)<br>Nobel Biocare Permanent Centric Post (K040573) |

## Device Description:

Nobel Biocare's NOBELREPLACE® Adapter is a hollow titanium alloy device intended for use as an accessory component designed to adapt a smaller platform abutment to a larger platform endosseous implant to a within the implant/abutment system.

The NOBELREPLACE® Adapter provides a gradual transition from abutment to implant, and can only be used as part of the implant/abutment system, not on its own. It is designed to remain a component of the implant/abutment system for as long as the implant remains in the patient's mouth.

Indications for Use:

Nobel Biocare's NOBELREPLACE® Adapter is a bushing that enables seating of a smaller diameter abutment to a larger diameter endosseous implant-supported dental restoration of a partially or fully edentulous jaw in order to restore patient esthetics and chewing function.

Nobel Biocare Traditional 510(k) Notification NOBELREPLACE® Adapter February 2005

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## Legally Marketed Device Information 2.4

The legally marketed equivalent devices are listed below:

| Predicate Device: | Replace Scalloped Margin Implant System |
|-------------------|-----------------------------------------|
| Predicate 510(k): | K021584 |
| Company: | Nobel Biocare |
| Predicate Device: | Nobel Biocare Permanent Centric Post |
| Predicate 510(k): | K040573 |
| Company: | Nobel Biocare |

A comparison of the attributes and intended use of the candidate device, NOBELREPLACE® A ocmpanoen of the atthe predicate device is provided in Section 2.5.

.

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| Section 2.5 | Substantial Equivalence Comparison to Predicate Devices | | |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ATTRIBUTE | CANDIDATE | PREDICATE | PREDICATE |
| | NOBELREPLACE® Adapter | Replace Scalloped Margin Implant System<br>(K021584) | Nobel Biocare Permanent Centric Post<br>(K040573) |
| Anatomical Site | • Oral Cavity | • Oral Cavity | • Oral Cavity |
| Abutment<br>Diameter | • 5.0 mm | • 3.5mm<br>• 4.3mm<br>• 5.0mm | • 3.5mm<br>• 4.3mm<br>• 5.0mm |
| Implant-Supported<br>Device | • Yes | • Yes | • Yes |
| Raw Material | • Titanium Vanadium Alloy | • Titanium Vanadium Alloy (abutments) | • Santoprene |
| Intended Use | • Permanent | • Permanent | • Permanent |
| Load-Bearing<br>Member of<br>Implant/Abutment<br>System | • Yes | • Yes | • No |
| Sterility | • Sterile | • Sterile (endosseous implants) | • Non-Sterile |
| Indications for Use | Nobel Biocare's NOBELREPLACE®<br>Adapter is a bushing that enables seating<br>of a smaller diameter abutment to a larger<br>diameter endosseous implant in an<br>implant-supported dental restoration of a<br>partially or fully edentulous jaw in order to<br>restore patient esthetics and chewing<br>function. | The Replace Scalloped Margin Implant System<br>is an implant with a scalloped coronal margin,<br>designed for single stage or two stage surgical<br>procedures. The Replace Scalloped Margin<br>Implant System is intended for use to restore<br>chewing function in edentulous and/or partially<br>edentulous patients. | The Nobel Biocare Permanent Centric Post is a<br>support component indicated for use as both an<br>alignment post to center an abutment, and as a<br>seal to prohibit fluids from seeping into the<br>implant interior. The Nobel Biocare Permanent<br>Centric Post is a component within the implant<br>system, and is intended for use in permanent<br>restorations in order to restore the chewing<br>function of fully edentulous and/or partially<br>edentulous patients. |

Nobel Biocare Traditional 510(k) Notification
NOBELREPLACE® Adapter
February 2005

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Image /page/3/Picture/1 description: The image shows the seal for the Department of Health and Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 7 - 2005

Mr. Herbert Crane Director of Regulatory Affairs Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K050444

Trade/Device Name: NOBELREPLACE® Adapter Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 9, 2005 Received: June 10, 2005

Dear Mr. Crane:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section Pre (--) fre device is substantially equivalent (for the relerenced above and have determined ure) to legally marketed predicate devices marketed in indications for use stated in the checked of the enactment date of the Medical Device interstate comments, or to that been reclassified in accordance with the provisions of Amendinents, of to devroes mat nave oose (Act) that do not require approval of a premarket the Federal FUOG, Drug, and Oosmette 110 (reso) , market the devices, subject to the general approval appreadon (1 Mr.). - 1 ou - any - roa - and - see include controls provisions of the rious and group of devices, good manufacturing practice, requirements for aibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into existing major regulations affecting (PMA), it may be subject to such acantenar connections, Title 21, Parts 800 to 898. In the Coderol your device can be found in the ecas nouncements concerning your device in the Federal Register.

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# Page 2 - Mr. Crane

Please be advised that FDA's issuance of a substantial equivalence d.stermination does not Please be advisod that I Dr. 3 issualled on that your device complies with other requirements mean that I DA nas made a deceminations administered by other Federal agencies. of the Act of ally I ederal butter and regirements, including, but not limited to: registration 1 ou must comply with an the Here's reg (21 CFR Part 801); good manufacturing practice and ifsung (21 CFR Part 067), laceling systems (QS) regulation (21 CFR Part 820); and if requirents as set forth in the quality brovisions (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) I his letter will anow you to begin mailering your substantial equivalence of your device to a premarket notheation. The FDF intents 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), II you desire specific advice for your do roll be 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 may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Birman [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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): |{οδοΥΨΥ

Device Name: NOBELREPLACE® Adapter

Indications For Use:

Nobel Biocare's NOBELREPLACE® Adapter is a bushing that enables seating of a smaller Nobel Bloodie 3 NOBEET endosseous implant in an implant in an implant-supported dental diameter abutinent to a farger atantilous jaw in order to restore patient esthetics and

chewing function.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Muly for KSR

(Division Sign-Off)
(Division of Anesthesiology, Geoeral Hospit (Division Sign-C Division of Anesthous Control, Dental
Infection Control, Dental 510(k) Number

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