VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT

K012473 · Vident · DZE · Sep 11, 2002 · Dental

Device Facts

• Record ID: K012473
• Device Name: VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT
• Applicant: Vident
• Product Code: DZE · Dental
• Decision Date: Sep 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Indications for Use

Ceramic hextop abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis. The ITI® ceramic coping is intended to be seated on the implant/abutment complex and serve as a base for the prosthetic reconstruction. The prefabricated coping provides a machined inner surface for mating with the abutment and implant, while the outer surface can be adapted to the individual restoration.

Device Story

Ceramic Hextop Abutment and SynOcta In-Ceram Coping function as components in dental implant systems; abutments seat directly on implant bodies to form prosthetic substructures; copings seat on implant/abutment complexes to serve as bases for individual prosthetic reconstructions. Used by dental professionals in clinical settings to facilitate tooth replacement. Devices provide mechanical interface between osseointegrated implants and final dental restorations; benefit patients by enabling stable, functional prosthetic attachment.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ceramic abutments and copings; designed for mechanical mating with commercially available osseointegrated dental implant systems; prefabricated with machined inner surfaces; non-osseointegrating.

Indications for Use

Indicated for patients requiring prosthetic restoration supported by osseointegrated dental implants. Used as a substructure or base for dental prostheses.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized eagle. The eagle is depicted with three horizontal lines forming its body and wings. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

SFP 1 1 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Barbara J. Lewandowski Vident 3150 East Birch Street Brea, California 92821

Re: K012473

Trade/Device Name: Ceramic Hextop Abutment and SynOcta® In-Ceram Coping Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: June 18, 2002 Received: June 21, 2002

Dear Mr. Lewandowski:

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.

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 -- Ms. Lewandowski

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 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

Timothy 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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### 510 (k) Number (if known):

Device Name: Ceramic Hextop Abutment

### Indications For Use:

Ceramic hextop abutments are designed for use with commercially available osseointegrated dental implant systems. The abutments, which do not osseointegrate, are to be seated directly on top of the implant body. The abutments form the substructure of the restored prosthesis.

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Prager

(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices

510(k) Number K012473

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use

(Optional Format 1-2-96)

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### 510 (k) Number (if known):

Device Name: ITI® Dental Implant System - Ceramic Coping

### Indications For Use:

The ITI® ceramic coping is intended to be seated on the implant/abutment complex and serve as a base for the prosthetic reconstruction. The prefabricated coping provides a machined inner surface for mating with the abutment and implant, while the outer surface can be adapted to the individual restoration.

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Remmo

(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices

510(k) Number K012473

Prescription Use / (Per 21 CFR 801.109)

OR

Over-The Counter Use

(Optional Format 1-2-96)