BELLUS SHADING KIT

K090718 · 3M Espe AG Dental Products · EIH · Sep 21, 2009 · Dental

Device Facts

• Record ID: K090718
• Device Name: BELLUS SHADING KIT
• Applicant: 3M Espe AG Dental Products
• Product Code: EIH · Dental
• Decision Date: Sep 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Color staining and glazing of glass ceramic restorations made from 3M ESPE's Glass Ceramics "Jolly".

Device Story

Bellus Shading Kit consists of stain pastes, glazing paste, and thinning liquid. Used by dental professionals in clinical settings to apply color stains and glaze to the surface of glass ceramic restorations (specifically 3M ESPE's "Jolly" glass ceramics). Pastes are applied to the restoration surface to achieve desired aesthetic shade and finish. The device functions as a surface treatment material to enhance the appearance of dental prosthetics. Benefits include improved aesthetic matching of restorations to natural dentition.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed to demonstrate safety. No clinical data provided.

Technological Characteristics

Kit includes stain pastes, glazing paste, and thinning liquid. Classified as porcelain powder for clinical use (21 CFR 872.6660). Material is intended for surface application on glass ceramic restorations.

Indications for Use

Indicated for color staining and glazing of glass ceramic dental restorations fabricated from 3M ESPE's "Jolly" glass ceramic blocks.

Regulatory Classification

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.

Predicate Devices

• IPS Empress Universal Shade/Stains (K980986)
• Glass Ceramics “Jolly” by 3M ESPE (K053438)
• Lava Ceram by 3M ESPE (K011394)
• Position Penta by 3M ESPE (K974231)

Submission Summary (Full Text)

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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: | [e-mail] |
| 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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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 [phone]. 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 [phone] or [phone] 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:

K090718

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:

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2nd Amendment K090718