(74 days)
No
The summary describes a light-curing coating material and its intended uses, with no mention of AI or ML technology in the device description, intended use, or any other section.
No
The device is a coating material used for sealing dental surfaces and protecting against discoloration, rather than treating a disease or condition. Its applications are restorative and protective, not therapeutic.
No
The device description indicates that EASY GLAZE is a coating material used for surface sealing and protection, which are therapeutic or restorative functions, not diagnostic ones.
No
The device description clearly states it is a "nanofilled, light-curing coating," indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described for EASY GLAZE are all related to the treatment and protection of dental restorations and tooth structure within the mouth. This is a direct application to the patient's body.
- Device Description: The description confirms it's a "nanofilled, light-curing coating" applied to surfaces.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition or provide information about a physiological state.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. EASY GLAZE is a material used directly in the dental treatment process.
N/A
Intended Use / Indications for Use
EASY GLAZE is intended for the following applications:
- Surface sealing of provisional crowns and bridges, glass ionomer cements and definitive composite restorations.
- Sealing the adhesive interfaces between restoration and tooth structure.
- Protecting glass ionomer cement surfaces against the effects of moisture and dehydration immediately after placement.
4 Sealing glass innomer cement liners/build-u restorations before taking impressions.
Product codes
EBD
Device Description
EASY GLAZE is a nanofilled, light-curing coating with natural fluorescence for sealing surfaces. The coated surface is luminous, provides protection against discolouration and yields a natural appearance. EASY GLAZE can be polymerised with all light-curing dental devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows a handwritten string of characters. The string appears to be a combination of letters and numbers. The characters are 'K082285'.
510(k) SUMMARY
Manfred Th. Plaumann Contact:
Date prepared: Auqust 04, 2008
EASY GLAZE Trade or proprietary name:
Coating, Filling Material, Resin (872.3310) Classification name:
1:052462 G-Coat Predicate device:
Device description: EASY GLAZE is a nanofilled, light-curing coating with natural fluorescence for sealing surfaces. The coated surface is luminous, provides protection against discolouration and yields a natural appearance. EASY GLAZE can be polymerised with all light-curing dental devices.
EASY GLAZE is intended for the following applications: Intended use:
-
- Surface sealing of provisional crowns and bridges, glass ionomer cements and definitive composite restorations.
-
- Sealing the adhesive interfaces between restoration and tooth structure.
-
- Protecting glass ionomer cement surfaces against the effects of moisture and dehydration immediately after placement.
-
- Sealing glass ionomer cement liners/build-up restorations before taking impressions.
Technological characteristics: All of the components of EASY GLAZE are found in the legally marketed devices K052462 (G-Coat, the prodicate device), K043168 (Biscover LV Bisco, Inc.) K974772 (Ufi Gel SC, VOCO GmbH) and K070306 (Paint-on Polish Agent, Dentsply International, Inc.).
The prior use of all of the components of EASY GI.AZE in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary.
We believe that the prior use of the components of EASY GLAZE in legally marketed devices and the performance data and results provided support the safety and effectiveness of EASY GLAZE for the intended use
VOCO GmbH, August 04th, 2008
Manfred Th. Plaumann Managing Board
OCT 2 4 2008
7-1
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Thorsten Gerkensmeier Regulatory Affairs VOCO GmbH Anton-Flettner-Strabe 1-3 27472 Cuxhaven GERMANY
OCT 2 4 2008
Re: K082285
Trade/Device Name: EASY GLAZE Regulation Number: 872.3310 Regulation Name: Coating Material for resin fillings Regulatory Class: II Product Code: EBD Dated: August 6. 2008 Received: August 11, 2008
Dear Dr. Gerkensmeier:
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.
2
Page 2 – Dr. Gerkensmeier
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. 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
J.H. Samuels Jr. for all
Chiu S. Lin. Ph. D Division 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 Statement
| 510(k) Number: | K0082285 |
|---|---|
| ---------------- | ---------- |
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
EASY GLAZE is intended for the following applications:
-
- Surface sealing of provisional crowns and bridges, glass ionomer cements and definitive composite restorations.
-
- Sealing the adhesive interfaces between restoration and tooth structure.
-
- Protecting glass ionomer cement surfaces against the effects of moisture and dehydration immediately after placement.
- 4 Sealing glass innomer cement liners/build-u restorations before taking impressions.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Please do not write below this line-continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suver Qusra
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Reviews Division of Antrol, Dental Devices
510(k) Number: K082285