(67 days)
Not Found
No
The summary describes a dental repair system with chemical components and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
ReVeneer is a repair system for ceramic crown and bridge veneers, which is restorative and not a therapeutic device.
No
The "Intended Use / Indications for Use" section describes the device as a "repair system for ceramic crown and bridge veneers," which is a treatment or restoration function, not a diagnostic one.
No
The device description lists physical components (Primer, Base, Opaquer, Composite Fillis) which are not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a system for repairing ceramic crown and bridge veneers. This is a dental procedure performed directly on a patient's teeth (intraoral) or on the dental restoration outside the mouth (extraoral).
- Device Description: The components listed (Primer, Base, Opaquer, Composite Fillis) are materials used in dental restorative procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
Therefore, ReVeneer is a dental restorative material system, not an in vitro diagnostic device.
N/A
Intended Use / 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)
Product codes
KLE, EIH, EBF
Device Description
ReVeneer Ceramic Repair System with the following components:
- Primer
- Base
- Opaquer (light and dark)
- Composite Fillis
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth/Dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K974089, K943165, K973247, K043119
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
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.(b)
Classification. Class II.
0
Schiltz-Dental GmbH · Die 61191 Rosbach / German
Phone: +49 (0) 6003-814-0
Fax: +49 (0) 6003-814-900 ... 906
info@schuetz-dental.de
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: +49/60 03/8 14-0
Contact person:
Mr. Michael Wierz
Phone: +49/60 03/8 14-367
Fax: +49/60 03/8 14-906
email: m.wierz@schuetz-dental.de
Date of Summary:
2005-08-09
Name of device:
ReVeneer Ceramic Repair System
with the following components:
- Primer
- Base
- Opaquer (light and dark)
- Composite Fillis
Classification name:
- Agent, Tooth Bonding, Resin
- Agent, Tooth Bonding, Resin
- Powder, Porcelain
- Material, Tooth Shade, Resin
Product code:
- KLE
- KLE
- ΕΙΗ
- EBF
C.F.R section:
- (872.3200)
- (872.3200)
- (872.6660)
- (872.3690)
Legally marketed
equivalent devices:
- Kuraray Alloy Primer
(510(k) no.: K974089) - Kuraray Clearfil Photo Bond
(510(k) no.: K943165) - Shofu Vintage Halo
1
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.
2
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 (240) 276-0115. 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 (301) 443-6597 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
3
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 ________________________________________________________________________________________________________________________________________________________________