(187 days)
Color staining and glazing of glass ceramic restorations made from 3M ESPE's Glass Ceramics "Jolly".
Bellus Shading Kit contains stain pastes, a glazing paste, and a liquid which can be used to thin the pastes. The pastes serve solely for the color staining and glazing of the surfaces of restorations made from "Jolly" glass ceramic blocks, manufactured for 3M ESPE.
This 510(k) premarket notification for the Bellus Shading Kit does not contain the detailed study information or acceptance criteria typically found for medical devices.
The filing primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety (biocompatibility) and intended use, rather than presenting a performance study with specific acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text. I will explain why each section cannot be answered from the document.
1. Table of acceptance criteria and reported device performance:
- Cannot be provided. The document states "To provide evidence for safety biocompatibility testing was carried out. The results show that Bellus Shading Kit is a safe device." However, it does not specify any quantitative acceptance criteria for biocompatibility nor does it report specific performance metrics for color staining and glazing. The assessment relies on the comparison of chemistry, performance data, and indications for use with predicate devices, implying qualitative rather than quantitative performance comparison.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. The document does not describe a clinical or performance test set. It mentions "biocompatibility testing," but no details about the sample size, study design (retrospective/prospective), or data provenance are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided. No test set or ground truth establishment process is described in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Cannot be provided. This device is a dental material (porcelain powder for clinical use), not an AI-powered diagnostic or therapeutic device. Therefore, a MRMC study or AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Cannot be provided. This device is a dental material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Cannot be provided. No specific ground truth methodology is described as there isn't a performance study in the document. The primary "truth" being established is substantial equivalence to predicate devices based on safety and intended use.
8. The sample size for the training set:
- Cannot be provided. No training set is applicable or described for this type of device.
9. How the ground truth for the training set was established:
- Cannot be provided. Not applicable.
In summary, the provided 510(k) pertains to a dental material (porcelain powder) and follows a substantial equivalence pathway, not a performance study with explicit acceptance criteria and detailed study results typical of more complex medical devices or software. The emphasis is on demonstrating that the device is safe and performs similarly to already legally marketed predicate devices, primarily through biocompatibility testing and a comparison of intended use and composition.
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1
SEP 2 1 2009
K090718
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitter
| Company: | 3M ESPE AG |
|---|---|
| Street: | ESPE Platz |
| ZIP-Code, City: | D-82229 Seefeld |
| Federal State: | Bavaria |
| Country: | Germany |
| Establishment Registration Number | 9611385 |
| Official Correspondent: | Dr. Desi W. Soegiarto, Regulatory Affairs Specialist |
| Phone: | 011-49-8152-700 1169 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | desi.soegiarto@mmm.com |
| Date: | March 13, 2009 |
Name of Device
| Proprietary Name: | Bellus Shading Kit |
|---|---|
| Classification Name: | Porcelain powder for clinical use |
| Common Name: | Colors, stains, shades, glaze |
Predicate Device
| IPS Empress Universal Shade/Stains by Ivoclar Vivadent | Presumably K980986 |
|---|---|
| Glass Ceramics “Jolly” by 3M ESPE | K053438 |
| Lava Ceram by 3M ESPE | K011394 |
| Position Penta by 3M ESPE | K974231 |
3M ESPE AG
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Description for the Premarket Notification
Bellus Shading Kit is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660). Bellus Shading Kit is intended to be used for color staining and glazing of glass ceramic restorations made from 3M ESPE's Glass Ceramics "Jolly" (K053438).
Bellus Shading Kit contains stain pastes, a glazing paste, and a liquid which can be used to thin the pastes. The pastes serve solely for the color staining and glazing of the surfaces of restorations made from "Jolly" glass ceramic blocks, manufactured for 3M ESPE.
To provide evidence for safety biocompatibility testing was carried out. The results show that Bellus Shading Kit is a safe device.
The comparison for chemistry, performance data and indications for use shows that Bellus Shading Kit is substantially equivalent to the predicate devices.
In summary, it can be concluded that safety and effectiveness requirements for Bellus Shading Kit are completely met.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle.
SEP 2 1 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Dr. Desi W. Soegiarto Regulatory Affairs Specialist 3M ESPE AG Dental Products ESPE Platz Seefeld, Bavaria GERMANY D-82229
Re: K090718
Trade/Device Name: Bellus Shading Kit Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: August 27, 2009 Received: August 31, 2009
Dear Dr. Soegiarto:
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 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.
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Page 2 - Dr. Soegiarto
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 yours,
fo
Susan Runner, D.D.S., M.A. Acting Division 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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2 Indication for Use
K0907/8
Indications for Use
51D(k) Number (if known):
Device Name:
Indications For Use:
Bellus Shading Kit
Color staining and glazing of glass ceramic restorations made from 3M ESPE's Glass Ceramics "Jolly".
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kei Mulvey for MIR
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page 1 of
2nd Amendment K090718
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.