(13 days)
ZirDent™ CAD/CAM Blocks are pre-formed ceramic dental blanks intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations (porcelain teeth).
ZirDent is a pre-formed machineable dental blank composed of zirconia ceramic (yttrium oxide stabilized zirconium oxide [YZTP]]. ZirDent is available in green (meaning "unfired") pre-formed blanks, partially-sintered (partially fired) pre-formed blanks and fully sintered (including hot isostatic press) pre-formed blanks. ZirDent is available in different shapes, shades, and dimensions according to the customers' / dental laboratories' specifications.
The provided text describes the 510(k) summary for the ZirDent™ CAD/CAM Blocks, a dental restorative material. The submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and testing against specific metrics. Therefore, the information needed to fully answer the request is not present in the provided document.
However, I can extract the available information and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Properties: | |
| As safe and effective as predicate devices (General) | Confirmed through testing (including ISO 6872) |
| Specific mechanical properties (e.g., flexural strength, fracture toughness, hardness, wear resistance) | Not specified in the provided text. The document only states "Testing (including ISO 6872) confirms ZirDent is as safe and effective as the predicate devices," implying these properties were evaluated but without providing specific numerical criteria or results. |
| Biocompatibility | Not specified in the provided text. While implied by "safe," no specific biocompatibility testing or criteria are mentioned. |
| Dimensional accuracy/fit after machining and sintering | Not specified in the provided text. Implied by CAD/CAM fabrication, but no criteria or performance data are given. |
| Aesthetics (shade match, translucency) | Not specified in the provided text. Implied by "shades" available, but no performance data. |
| Long-term durability/clinical performance | Not specified in the provided text. |
Study Information (Based on available text):
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document does not specify the sample size used for any testing.
- The document does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- This type of information is not applicable to this submission. The submission is for a material, not a diagnostic or AI device that requires expert ground truth for interpretation. The "ground truth" for a material would typically be established by standardized material testing methods and physical property measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This is not applicable as the study is not an interpretative study requiring human adjudication of results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done. This is a submission for a dental material, not an AI or diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not applicable as this is not an AI or algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a material, the "ground truth" for performance would be established by standardized material testing methods (e.g., ISO 6872 for dental ceramics) to measure physical and mechanical properties. The text states "Testing (including ISO 6872) confirms ZirDent is as safe and effective as the predicate devices," indicating that these standardized tests were the basis for evaluating "ground truth" regarding material properties.
8. The sample size for the training set
- This is not applicable as there is no mention of a "training set." This device is a ceramic material, not an AI or machine learning algorithm that requires training data.
9. How the ground truth for the training set was established
- This is not applicable as there is no training set for this type of device.
Summary of what the document does provide regarding the study:
- Study Type: The study was a substantial equivalence testing against predicate devices, specifically involving "Testing (including ISO 6872)." ISO 6872 is a standard for dental ceramics, indicating that physical and mechanical properties were evaluated.
- Conclusion: The testing led to the conclusion that "ZirDent is as safe and effective as the predicate devices noted in this submission."
- Predicate Devices: Katana Zirconia (K050160), ZirBlank PS & FS (K070045), Zerion (K061804), Xavex-G100 (K050903).
To fully answer the request, more detailed technical documentation of the testing performed for the 510(k) submission would be needed, including specific test methods, sample sizes for those tests, and the numerical results compared against acceptance criteria defined by the ISO 6872 standard or other relevant material standards.
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Section 2: 510(k) Summary
MAY 15 2008
510(k) Owner: C5 Medical Werks 2451 River Road Grand Junction, CO 81505 Phone No. 970/683-7900 Fax No. 970/683-7999
Contact Person: Homer Gregory Director, Quality Assurance and Regulatory Compliance Phone No. 970/683-7900
Date of Summary: April 2, 2008
Name of Device:
Trade name - ZirDent™ CAD/CAM Blocks
Common name - Dental restorative material, ceramic dental blanks
Classification name – Porcelain powder for clinical use (21 CFR 872.6660). Class II. Product Code EIH.
*Legally marketed devices to which C5 Medical Werks is claiming equivalence:
Katana Zirconia - 510(k) number K050160 ZirBlank PS & FS - 510(k) number: K070045 Zerion - 510(k) number: K061804 Xavex-G100 - 510(k) number: K050903
*510(k) data for these devices is available on FDA's CDRH website.
Continued on next page ...
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Section 2: 510(k) Summary (continued)
Description of device: ZirDent is a pre-formed machineable dental blank composed of zirconia ceramic (yttrium oxide stabilized zirconium oxide [YZTP]]. ZirDent is available in green (meaning "unfired") pre-formed blanks, partially-sintered (partially fired) pre-formed blanks and fully sintered (including hot isostatic press) pre-formed blanks. ZirDent is available in different shapes, shades, and dimensions according to the customers' / dental laboratories' specifications.
Indications for use:
ZirDent is a pre-formed ceramic dental blank intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations.
ZirDent is designed for manufacturing ceramic dental restorations such as single crowns or bridgeworks. The ceramic dental blank is machined by the customers/dental laboratories on their milling centers or similar equipment using CAD/CAM techniques for design and processing to the patient-specific anterior/posterior tooth/bridge specification provided by the dental practitioner. For the green and partially-sintered pre-formed blanks, the customer/dental laboratory completes the sintering process after machining the patient-specific crown/bridge.
Summary of technological characteristics: water insoluble, pre-formed YTZP ceramic dental blank designed to be machined into a crown or bridge per the dental practitioners' specifications. These technological characteristics are identical to the predicate devices noted in this submission.
Substantial equivalence: Testing (including ISO 6872) confirms ZirDent is as safe and effective as the predicate devices noted in this submission.
Conclusion: ZirDent is substantially equivalent to the predicate devices indicated in this submission.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 5 2008
C5 Medical Werks, Incorporated C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K081253
Trade/Device Name: ZirDent™ CAD/CAM Blocks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: April 30, 2008 Received: May 2, 2008
Dear Mr. Lehtonen:
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. Lehtonen
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chris Liu, 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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Section 1: Indications for Use Statement
510(k) Number:_KO&125 3
Device Name: ZirDenf™ CAD/CAM Blocks________________________________________________________________________________________________________________________________
Indications for Use: ZirDent™ CAD/CAM Blocks are pre-formed ceramic dental blanks intended for CAD/CAM fabrication of zirconia frameworks for all-ceramic dental restorations (porcelain teeth).
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruaper
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081253
§ 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.