(187 days)
Not Found
No
The device description and intended use are solely focused on physical materials (pastes and liquid) for staining and glazing dental restorations, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is used for color staining and glazing of glass ceramic restorations, not for treating or diagnosing medical conditions.
No
The device description indicates that the Bellus Shading Kit is used for "color staining and glazing of the surfaces of restorations." This process is used to alter the appearance of a restoration and does not involve diagnosing a medical condition or disease.
No
The device description explicitly states it contains "stain pastes, a glazing paste, and a liquid," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Color staining and glazing of glass ceramic restorations". This is a process applied to a dental restoration outside of the body, not a test performed on a biological sample to diagnose a condition.
- Device Description: The device consists of "stain pastes, a glazing paste, and a liquid". These are materials used for surface treatment, not reagents or instruments for analyzing biological samples.
- Lack of Biological Sample Analysis: There is no mention of the device being used to analyze blood, urine, tissue, or any other biological sample.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely related to the aesthetic and functional finishing of dental restorations.
N/A
Intended Use / Indications for Use
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).
Color staining and glazing of glass ceramic restorations made from 3M ESPE's Glass Ceramics "Jolly".
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Presumably K980986, K053438, K011394, K974231
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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.
2
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.
3
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
4
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