GLASS CERAMICS

K053438 · 3M Espe AG Dental Products · EIH · Jan 18, 2006 · Dental

Device Facts

• Record ID: K053438
• Device Name: GLASS CERAMICS
• Applicant: 3M Espe AG Dental Products
• Product Code: EIH · Dental
• Decision Date: Jan 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Manufacture of all-ceramic inlays, onlays, crowns, and veneers.

Device Story

Glass ceramic blocks used to manufacture all-ceramic inlays, onlays, crowns, and veneers. Blocks are grindable materials for CAD/CAM systems. Used in dentist offices or dental laboratories via the CEREC system (Sirona). Clinical situation is optically scanned; processed by CEREC 3D software; restoration fabricated in CEREC grinding unit. Provides dentists with a method to create custom dental restorations.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of material properties and intended use to legally marketed predicate devices.

Technological Characteristics

Glass ceramic blocks available in six colors and five sizes. Designed for use with CAD/CAM grinding systems. Classified as porcelain powder for clinical use (21 CFR 872.6660).

Indications for Use

Indicated for the manufacture of all-ceramic inlays, onlays, crowns, and veneers in patients requiring dental restorations.

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

• Lava Ccram™ / Lava Frame™ by 3M ESPE (K0113949)
• Paradigm™ MZ 100 block by 3M ESPE (K9204259)
• ProCAD® by Ivoclar Vivadent Inc. (K980986)
• VITABLOCS® Mark II by VITA Zahnfabrik H. Rauter GmbH & Co. KG (K022408)

Reference Devices

• CEREC® system (K012517)

Submission Summary (Full Text)

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# . ਜੋ ਮੈ

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

## JAN 1 8 2006

| 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. Andreas Petermann, |
| | Manager Regulatory Affairs |
| Phone: | 011-49-8152-700 1395 |
| Fax: | 011-49-8152-700 1869 |
| E-mail: | [e-mail] |
| Date: | December 7, 2005 |

### traditional 510(k) GLASS CERAMICS

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| Name of Device | |
|---------------------|-----------------------------------|
| Proprietary Name: | GLASS CERAMICS |
| Classification Name | Porcelain powder for clinical use |
| Common Name: | Glass ceramic blocks |

#### Predicate Devices:

Lava Ccram™ / Lava Frame™ by 3M ESPE (K0113949) Paradigm™ MZ 100 block by 3M ESPE (K9204259) ProCAD® by Ivoclar Vivadent Inc. (presumably K980986) VITABLOCS® Mark II by VITA Zahnfabrik H. Rauter GmbH & Co. KG (presumably K022408)

#### Description for the Premarket Notification

GLASS CERAMICS are classified as Porcelain powder for clinical use ( 21 C.F.R. \$872.6660). They are glass ceramic blocks intended to manufacture all-ceramic inlays, onlays, crowns, and vencers. GLASS CERAMICS blocks are available in six colors (A1; A2; A3; A3.5; B3; Enamel) and five sizes (I8, 110, 112, I14, V5-12).

Like the predicate devices, the glass ccramic blocks "ProCAD® blocks" and "VITABLOCS® Mark II" and the composite block "Paradigm™ MZ 100" blocks, GLASS CERAMICS blocks are grindable blocks for CAD/CAM systems. The allccramic restoration is produced in the dentist's office using the CEREC® system or in a dental laboratory using CEREC® Inlab; both systems are manufactured by the company Sirona, Bensheim, Germany (K012517). The clinical situation is optically scanned and then processed by the CEREC® 3D software. The restoration is fabricated in the CEREC® grinding unit.

Comparison to the predicate devices for composition, performance data and indications for use shows that GLASS CERAMICS are substantially equivalent to the predicate devices. In summary it can be concluded that safety and effectiveness requirements for GLASS CERAMICS arc fully met.

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JAN 1 8 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Dr. Sabine Krischer Regulatory Affairs Specialist 3M ESPE AG ESPE Platz Seefeld, D-82229 GERMANY

Re: K053438

Trade/Device Name: Glass Ceramics Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 07, 2005 Received: December 09, 2005

Dear Dr. Krischer:

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.

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#### Page 2 – Dr. Sabine Krischer

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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,

Chiu S. Lin, PhD

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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## Indications for Use

K053438 510(k) Number (if known):

Device Name: Glass Ceramics Indications for Use:

Manufacture of all-ceramic inlays, onlays, crowns, and veneers.

Prescription Use × (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruanes

A (1) 2 (1) 1) nn of Annot Pasielogy, General Hospital, . Fon Control, Dental Devices

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