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

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.

AI/ML Overview

The provided text describes a 510(k) submission for the NOBELREPLACE® Adapter, a dental device. However, it does not contain any information regarding specific acceptance criteria, performance studies, or clinical trials. The document primarily focuses on establishing substantial equivalence to predicate devices based on design and intended use.

Therefore, I cannot provide the requested information. The text does not include:

A table of acceptance criteria and reported device performance: No performance data is presented.
Sample size used for the test set and data provenance: No test set or study is described.
Number of experts used to establish ground truth and their qualifications: No ground truth establishment is mentioned.
Adjudication method: Not applicable as no study is described.
Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
Standalone (algorithm-only) performance: Not applicable as this is a physical dental device, not an AI algorithm.
Type of ground truth used: Not applicable as no study data is presented.
Sample size for the training set: Not applicable as this is not a machine learning device.
How ground truth for the training set was established: Not applicable.

The document states that the NOBELREPLACE® Adapter is a hollow titanium alloy device used to adapt a smaller platform abutment to a larger platform endosseous implant. The 510(k) submission focuses on comparing its attributes and intended use to existing legally marketed devices (Replace Scalloped Margin Implant System and Nobel Biocare Permanent Centric Post) to demonstrate substantial equivalence, rather than presenting results from a performance study against acceptance criteria.

Summary

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Koso444

JUL 7 - 2005

510(k) Summary of Safety and Effectiveness 1.4

Submitted by:	Elizabeth J. MasonSr. Regulatory Affairs Specialist
Address:	Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887
Telephone:	(714) 282-4800, ext. 7830
Facsimile:	(714) 282-9023
Date of Submission:	February 18, 2005
Classification Name:	Endosseous Dental Implant Abutment (21 CFR 872.3630)
Trade or Proprietaryor Model Name:	NOBELREPLACE® Adapter
Legally Marketed Device(s):	Replace Scalloped Margin Implant System (K021584)Nobel Biocare Permanent Centric Post (K040573)

Device Description:

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(K021584)	Nobel Biocare Permanent Centric Post(K040573)
Anatomical Site	• Oral Cavity	• Oral Cavity	• Oral Cavity
AbutmentDiameter	• 5.0 mm	• 3.5mm• 4.3mm• 5.0mm	• 3.5mm• 4.3mm• 5.0mm
Implant-SupportedDevice	• Yes	• Yes	• Yes
Raw Material	• Titanium Vanadium Alloy	• Titanium Vanadium Alloy (abutments)	• Santoprene
Intended Use	• Permanent	• Permanent	• Permanent
Load-BearingMember ofImplant/AbutmentSystem	• Yes	• Yes	• No
Sterility	• Sterile	• Sterile (endosseous implants)	• Non-Sterile
Indications for Use	Nobel Biocare's NOBELREPLACE®Adapter is a bushing that enables seatingof a smaller diameter abutment to a largerdiameter endosseous implant in animplant-supported dental restoration of apartially or fully edentulous jaw in order torestore patient esthetics and chewingfunction.	The Replace Scalloped Margin Implant Systemis an implant with a scalloped coronal margin,designed for single stage or two stage surgicalprocedures. The Replace Scalloped MarginImplant System is intended for use to restorechewing function in edentulous and/or partiallyedentulous patients.	The Nobel Biocare Permanent Centric Post is asupport component indicated for use as both analignment post to center an abutment, and as aseal to prohibit fluids from seeping into theimplant interior. The Nobel Biocare PermanentCentric Post is a component within the implantsystem, and is intended for use in permanentrestorations in order to restore the chewingfunction of fully edentulous and/or partiallyedentulous 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 (240) 276-0115. 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 (301) 443-6597 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

Page 1 of 1

1.3

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)