OBSIDIAN CERAMIC BLOCKS

K100781 · Prismatik Dentalcraft, Inc. · EIH · Jun 21, 2010 · Dental

Device Facts

• Record ID: K100781
• Device Name: OBSIDIAN CERAMIC BLOCKS
• Applicant: Prismatik Dentalcraft, Inc.
• Product Code: EIH · Dental
• Decision Date: Jun 21, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is used to fabricate ceramic dental prostheses in the nature of crowns and bridges for posterior and anterior applications using CAD/CAM or hot-press methods.

Device Story

Obsidian™ Ceramic Blocks are lithium silicate glass ceramic blanks used by dental professionals to fabricate dental prostheses. The material is processed via CAD/CAM milling or hot-press methods to create crowns, bridges, veneers, inlays, and onlays. The device utilizes germanium dioxide instead of lanthanum oxide to achieve improved density and flexural strength compared to traditional lithium disilicate glass ceramics. The final restorations are placed by clinicians to restore dental function and esthetics. The device is intended for prescription use.

Clinical Evidence

Clinical data provided for 16 patients receiving 28 custom restorations (27 crowns, 1 inlay) fabricated via CAD/CAM. Restorations were monitored for 3 to 9 months. All restorations performed as expected with no replacements required, demonstrating excellent esthetics and functional stability.

Technological Characteristics

Lithium silicate glass ceramic material containing germanium dioxide. Form factor: ceramic blocks/blanks. Processing: CAD/CAM milling or hot-press methods. Characteristics: improved density and flexural strength compared to lithium disilicate glass ceramics.

Indications for Use

Indicated for fabrication of ceramic dental prostheses, including crowns, bridges, veneers, inlays, and onlays, for posterior and anterior applications in patients requiring dental restoration.

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 e.max CAD/IPS e.max ZirCAD (K051705)
• IPS Empress 2 (K982616)

Submission Summary (Full Text)

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K100781

### 510(k) Summary (K100781)

#### Submitter:

JUN 2 1 2010

Prismatik Dentalcraft, Inc. 4141 MacArthur Blvd. Newport Beach, CA 92660

Contact Person(s):

Keith D. Allred, 949-440-2683 (p) / 949-440-2787 (f) and consultants, Robin Carden & Wolfgang Freibauer

Date of Application: March 15, 2010

ldentification of the Device: Obsidian™ Ceramic Blocks, product code "EIH," non-exempt Class II (CFR §872.6660 - Porcelain powder for clinical use)

Substantial Equivalence: The device is substantially equivalent to other legally marketed devices in the United States. Substantially equivalent devices include the following: (1) IPS e.max CAD/IPS e.max ZirCAD (Ivoclar, K051705); and (2), IPS Empress 2 (Ivoclar, K982616).

Description of the Device: The device is comprised of dental porcelain powder in the nature of a lithium silicate glass ceramic that is used in the form of ceramic blanks. The device has excellent casting and machining properties and can be used to obtain highly esthetic dental restorations with desirable characteristics including improved density and flexural strength compared to predicate devices.

Indications for Use: The device is used to fabricate ceramic dental prostheses in the nature of crowns and bridges for posterior and anterior applications using CAD/CAM or hot-press methods.

Safety and Efficacy: Studies comparing the subject device to predicate devices (e.max CAD-K051705 and IPS Empress 2 - K982616) demonstrate that the subject device is safe and effective for use fabricating restoratives in the nature of ceramic crowns, bridges, veneers, inlays and onlays using CAD/CAM and press-ceramic methods. Both the subject and predicate devices are lithium silicon glass ceramics and substantially identical in that they use the same basic components. The predicate devices contain lanthanum oxide whereas the subject device uses germanium dioxide, resulting in a lithium silicate glass ceramic with increased final density and higher values of flexural strength compared to lithium disilicate glasses.

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Additionally, clinical data was provided for investigational purposes. CAD/CAM methods were used to mill twenty-eight custom made restorations using the subject device, comprising 27 crowns and 1 inlay for 16 patients. All of the restorations were placed from October 2, 2009 through May 4, 2010 demonstrating excellent esthetics (9 of the restorations have been in place from 6 to 9 months and 23 restorations have been in place for more than 3 months). All 28 restorations are performing as expected based on the physical properties of the subject device as determined in the nonclinical testing with no replacements required.

Conclusions drawn from the nonclinical and clinical data demonstrate that the subject device functions in a similar manner to other comparative devices and the intended use is the same. The fundamental scientific technology of the subject device has not changed relative to the predicate devices and the differences between the subject and predicate devices are minor and do not raise new safety concerns. The effectiveness and suitability to the intended purpose of the subject device are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification and are assured through wide, general use of similar other predicate devices that demonstrate the safe use of the subject device to construct dental restorations.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

# JUN 2 1 2010

Mr. Keith Allred Prismatik Dentalcraft, Incorporated 4141 MacArthur Boulevard Newport Beach, CA 92660

Re: K100781

Trade/Device Name: Obsidian" Ceramic Blocks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH Dated: May 19, 2010 Received: May 24, 2010

Dear Mr. Allred:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 - Mr. Allred

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/Offices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Susan Penner

WAnthony D. Watson, B.S., M.S., M.B.A. 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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#### Schedule B

### Indications for Use Statement

- 510(k) Number (if known): K100781 ♪
- Device Name: Obsidian™ Ceramic Blocks ▼
- Indications for Use: ♪

The device is used to fabricate ceramic dental prostheses in the nature of crowns and bridges for posterior and anterior applications using CAD/CAM or hot-press methods.

Prescription Use X (Part 21 CFR 801 SubpartD) AND/OR

Over-The-Counter Use (21 CFR 801 SubpartC)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Kein Maduy for MSR

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K100781