(63 days)
No
The summary describes a pre-formed material for dental prosthetics and focuses on material properties and equivalence to predicate devices, with no mention of AI or ML.
No.
ZirBlock® is a pre-formed material used in the manufacture of dental prosthetics, not directly applied for treating or diagnosing a disease or condition. It's a component for creating medical devices, not a therapeutic device itself.
No
Explanation: The device, ZirBlock®, is a pre-formed material used in the manufacture of dental prosthetics. Its intended use as described is for creating physical dental devices (crowns, bridges, inlays, and onlays) and not for diagnosing any medical conditions or diseases.
No
The device description clearly states that ZirBlock® is a "pre-formed material," indicating it is a physical substance, not software.
Based on the provided information, ZirBlock® is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "manufacture of dental prosthetics: crowns, bridges, inlays, and onlays." This is a manufacturing process for medical devices, not a diagnostic test performed on biological samples.
- Device Description: It's described as a "pre-formed material for use by dental laboratories." This further reinforces its role as a component in the manufacturing process.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
- Regulatory Classification: The reference to "IDENTIFICATION of porcelain powders in 21 CFR 872.6660" suggests it falls under a different regulatory classification related to dental materials, not IVDs.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. ZirBlock® does not fit this description.
N/A
Intended Use / Indications for Use
ZirBlock® is used in the manufacture of dental prosthetics: crowns, bridges, inlays, and onlays.
Product codes
EIH
Device Description
ZirBlock® is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics
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)
None required. The claim of substantial equivalence is based on comparisons 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
KaVo Everest ZS-Blank K03281, 3M "Lava" K053438, Vident VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL2 K052130, ZIRKONZAHN GMBHZIRKONZAHN ICE K061851
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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
Page 1 of 1
- Sign-Off)
Lusion of Anesthesiology, General Hospital,
rection Control, Dental Devices
3(k) Number: K040537