ZIRBLOCK

K070537 · Cdl Technologies, Inc. · EIH · Apr 30, 2007 · Dental

Device Facts

• Record ID: K070537
• Device Name: ZIRBLOCK
• Applicant: Cdl Technologies, Inc.
• Product Code: EIH · Dental
• Decision Date: Apr 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

ZirBlock® is used in the manufacture of dental prosthetics: crowns, bridges, inlays, and onlays.

Device Story

ZirBlock® is a pre-formed material used by dental laboratories to fabricate dental prosthetics, specifically crowns, bridges, inlays, and onlays. The device serves as a raw material substrate for dental restoration manufacturing. It is intended for professional use in a laboratory setting to fulfill dental prescriptions. The material is processed into final prosthetic shapes to restore dental function and aesthetics for patients requiring tooth replacement or repair.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing comparisons of formulations and mechanical characteristics.

Technological Characteristics

Pre-formed dental frame material. Classified as porcelain powder for clinical use (21 CFR 872.6660).

Indications for Use

Indicated for the manufacture of dental prosthetics including crowns, bridges, inlays, and onlays.

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

• KaVo Everest ZS-Blank (K03281)
• 3M Lava (K053438)
• Vident VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL2 (K052130)
• ZIRKONZAHN GMBH ZIRKONZAHN ICE (K061851)

Submission Summary (Full Text)

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### EXHIBIT 2 510(k) SUMMARY: CDL Technologies Inc. ZirBlock®

This 510(k) summary for CDL Technologies Inc.. ZirBlock® material is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

- Applicant: CDL Technologies, Inc
- 645 Front St., Suite 2007 Address: San Diego, Ca 92101

Contact Person: Mr. Radoslav Kalla

APR 3 0 2007

Manufacturer: Keramo Technical Ceramics Via Rovescio 56 22038 Tavernerio COMO - Italy

Preparation Date: February 20, 2007

Device Name: ZirBlock® Common Name: Dental Frame Material for Dental Prosthesis Classification: Porcelain, powder for clinical use 21 CFR 872.6660 Class II medical device Product Code: EIH Panel: 76

KaVo Everest ZS-Blank K03281 and 3M "Lava" K053438 and Vident VITA Predicate devices: IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL2 K052130 and ZIRKONZAHN GMBHZIRKONZAHN ICE K061851, among others.

- ZirBlock® is a pre-formed material for use by dental laboratories in filling Device description: orders/prescriptions for dental prosthetics
- ZirBlock® is used in the manufacture of dental prosthetics: crowns, bridges, Indications: inlays, and onlays.
- None required. The claim of substantial equivalence is based on comparisons Performance Data: of formulations, mechanical characteristics, and intended uses of the devices to legally marketed predicates and to the IDENTIFICATION of porcelain powders in 21 CFR 872.6660.
- Based on the information in the notification CDL Technologies, Inc. believes CONCLUSION: that ZirBlock® is substantially equivalent to cited legally marketed predicates and to the IDENTIFICATION in the classifying regulation (21 CFR 872.6660).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CDL Technologies, Incorporated C/O Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

APR 3 0 2007

Re: K070537

Trade/Device Name: ZirBlock® Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: February 22, 2007 Received: March 5, 2007

Dear Mr. Kamm:

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 - Mr. Kamm

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" (21CFR 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,

Clive
Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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

510(k) Number (if known): K070537

Device Name: ZirBlock®

#### Indications for Use:

ZirBlock® is used in the manufacture of dental prosthetics: crowns, bridges, inlays, and onlays.

Prescription Use _ X (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)

Susa Rumpe

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1. Sign-Off)
Lusion of Anesthesiology, General Hospital,
rection Control, Dental Devices

3(k) Number: K040537