REVENEER CERAMIC REPAIR SYSTEM

K052189 · Schutz-Dental GmbH · KLE · Oct 17, 2005 · Dental

Device Facts

• Record ID: K052189
• Device Name: REVENEER CERAMIC REPAIR SYSTEM
• Applicant: Schutz-Dental GmbH
• Product Code: KLE · Dental
• Decision Date: Oct 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

ReVeneer is an intraoral and extraoral repair system for ceramic crown and bridge veneers with the following advantages: - no acid etching (neither hydrofluoric nor phosphoric acid) - safe intraoral use - extremely good bond strength - time saving - can be used universally, with all conventional ceramics - use of conventional curing lights (halogen, LED, plasma)

Device Story

ReVeneer Ceramic Repair System is a multi-component dental kit for repairing ceramic crowns and bridges. System includes primer, base, opaquer (light/dark), and composite filler. Used intraorally and extraorally by dentists to restore ceramic veneers without hydrofluoric or phosphoric acid etching. Components applied to ceramic surface to facilitate bonding; cured using conventional dental lights (halogen, LED, plasma). Provides high bond strength; universal compatibility with conventional ceramics. Benefits include time efficiency and avoidance of harsh etching acids.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Dental resin bonding and ceramic repair system. Components: primer, resin base, opaquer, and composite filler. Curing mechanism: light-activated polymerization (halogen, LED, plasma). Universal compatibility with conventional dental ceramics. No acid etching required.

Indications for Use

Indicated for intraoral and extraoral repair of ceramic crown and bridge veneers in patients requiring dental restoration.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Predicate Devices

• Kuraray Alloy Primer (K974089)
• Kuraray Clearfil Photo Bond (K943165)
• Shofu Vintage Halo (K973247)
• Ultradent Amelogen Plus (K043119)

Submission Summary (Full Text)

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Schiltz-Dental GmbH · Die 61191 Rosbach / German

Phone: [phone]
Fax: [phone] ... 906
[e-mail]

Geschäftsführer:
Horst Schütz • Wolf Zientz

iedbera HRB 156

K 052189

Premarket Notification 510(k)

## 510(k) Summary

**510(k) Summary**

Submitter of 510(k):
Schütz-Dental GmbH
Dieselstr. 5-6
61191 Rosbach
Germany
Phone: [phone]

Contact person:
Mr. Michael Wierz
Phone: [phone]
Fax: [phone]
email: [e-mail]

Date of Summary:
2005-08-09

Name of device:
ReVeneer Ceramic Repair System
with the following components:
1. Primer
2. Base
3. Opaquer (light and dark)
4. Composite Fillis

Classification name:
1. Agent, Tooth Bonding, Resin
2. Agent, Tooth Bonding, Resin
3. Powder, Porcelain
4. Material, Tooth Shade, Resin

Product code:
1. KLE
2. KLE
3. ΕΙΗ
4. EBF

C.F.R section:
1. (872.3200)
2. (872.3200)
3. (872.6660)
4. (872.3690)

Legally marketed
equivalent devices:
1. Kuraray Alloy Primer
(510(k) no.: K974089)
2. Kuraray Clearfil Photo Bond
(510(k) no.: K943165)
3. Shofu Vintage Halo

- 3. Shofu Vintage Halo (510(k) no .: K973247) 4. Ultradent Amelogen Plus
- (510(k) no .: K043119)

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is written around the circumference of the circle.

OCT 17 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael Wierz Export Sales Manager Schütz Dental GmbH Dieselstr. 5-6 Rosbach Hessen 61191 GERMANY

Re: K052189

Trade/Device Name: Reveneer Ceramic Repair System Regulation Number: 21 CFR 872.3200 Regulation Namc: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: August 9, 2005 Received: August 16, 2005

Dear Mr. Wierz:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beener over 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 Interstate commerce proces that have been reclassified in accordance with the provisions of Amendinents, or to actrices and metic Act (Act) that do not require approval of a premarket the I cuchar I ood, Drag, and Obbu may, therefore, market the device, subject to the general approvin upprisation (The Act. The general controls provisions of the Act include controls provisions of the or the 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 If your device is classified (000 additional controls. Existing major regulations affecting (1 MA), it may of sable of Federal Regulations, Title 21, Parts 800 to 898. In your device can be foundsh further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Wierz

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I Dri-s issualled on that your device complies with other requirements mean that FDA nas made a decormination administered by other Federal agencies. of the Act of ally I ederal statutes and regarements, including, but not limited to: registration You must comply with an the Act 8 required.com); good manufacturing practice and listing (21 CFR Part 607), laboling (21 cms (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); requirements as set forth in the quality Systems (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 ins letter will anow you to objail finding of substantial equivalence of your device to a premiarket notification. The PDA midness or 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), If you desire specific advice for your de at [phone]. Also, please note the regulation prease contact the Other or Comphanes and (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 01 01628-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Punneo
Shin Lin, Ph.D.

r, 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): | K052189 |
|---------------------------|--------------------------------|
| Device Name: | Reveneer Ceramic Repair System |
| Indications for Use: | |

ReVeneer is an intraoral and extraoral repair system for ceramic crown and bridge veneers with the following advantages:

- no acid etching (neither hydrofluoric nor phosphoric acid)
- safe intraoral use
- extremely good bond strength
- time saving
- can be used universally, with all conventional ceramics
- use of conventional curing lights (halogen, LED, plasma)

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Please Do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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

Susan Runser

Page of

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

510(k) Number ________________________________________________________________________________________________________________________________________________________________