(97 days)
The indications for use for DC-Cristall is as a substructure for single unit porcelain fused ceramic fixed dental restorations; namely crowns. Substructures of DC-Cristall are machined using the DCS Precident CAD/CAM System.
The DC-Cristall material is a glass ceramic material, furnished in a block form, designed for use as feed stock in the DCS Precident CAD/CAM System.
This describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the DC-Cristall material.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 6872:1999 Dental Ceramics) | Reported Device Performance (DC-Cristall) |
|---|---|
| Mechanical Strength | Complies with ISO 6872:1999 |
| Chemical Solubility | Complies with ISO 6872:1999 |
| Biocompatibility | Complies with ISO 6872:1999 |
| Dimensional Stability | Complies with ISO 6872:1999 |
| Esthetics | Not explicitly detailed but implied by "porcelain fused ceramic" |
Note: The provided document states that "The safety and efficacy of DC-Cristall is assured by compliance with ISO 6872:1999 Dental Ceramics." However, it does not provide specific numerical values or detailed test results for each criterion. It only asserts overall compliance.
2. Sample Size and Data Provenance for the Test Set
The document does not explicitly specify a "test set" in the context of an AI/ML device. Instead, it refers to standard testing of the material itself.
- Sample Size: Not explicitly stated for specific tests, but testing would have been conducted on an appropriate number of DC-Cristall material samples to satisfy the requirements of ISO 6872:1999.
- Data Provenance: Not specified, but standard material testing would typically be performed in a laboratory setting, likely in the country of origin of the manufacturer (USA, based on the address). This would be analogous to a prospective study of material properties.
3. Number of Experts and Qualifications for Ground Truth - Test Set
Not applicable in the context of an AI/ML device. This refers to material scientists and engineers who would conduct the tests and assess compliance with ISO 6872:1999. Their qualifications would be expertise in dental materials testing and adherence to international standards.
4. Adjudication Method for the Test Set
Not applicable in the context of an AI/ML device. Compliance with ISO 6872:1999 would be determined by whether the test results meet the specified thresholds and requirements of the standard, not by expert adjudication of interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. The DC-Cristall is a material for dental restorations, not an AI/ML diagnostic or assistive device that would involve human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a material, not an algorithm. The "performance" is its compliance with material standards.
7. Type of Ground Truth Used
The ground truth used is the standards set forth in ISO 6872:1999 Dental Ceramics. This standard defines the acceptable physical, mechanical, chemical, and biological properties for dental ceramic materials. Compliance with all specified tests and thresholds within this standard constitutes the "ground truth" for the material's safety and efficacy.
8. Sample Size for the Training Set
Not applicable. This is a material, not an AI/ML model that requires a training set. The development of the material would involve R&D and formulation iterations, but not "training data" in the AI sense.
9. How Ground Truth for the Training Set Was Established
Not applicable. As noted above, this is a material, not an AI/ML model. The "ground truth" for material development would be established through established scientific principles, material science research, and iterative testing against desired performance specifications, which would eventually lead to the formulation meeting ISO standards.
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KO11674
510(k) Premarket Notification Summary
Austenal Inc.
Name & Address:
AUSTENAL, INC. 5101 S. Keeler Ave Chicago, IL 60632-4287 (773) 735-0600 FAX (773) 735-3940
Contact: Ronald Dudek
Date Prepared: August 23, 2001
Trade or Proprietary Name: DC-Cristall for the DCS Precident CAD/CAM System
76EIH -Powder, Porcelain, Classification Name: Note: At this time a classification does not exist for a solid ceramic material. 76EIH is the closest based on intended use.
Device Description: The DC-Cristall material is a glass ceramic material, furnished in a block form, designed for use as feed stock in the DCS Precident CAD/CAM System.
Intended Use: The indications for use for DC-Cristall is as a substructure for single unit porcelain fused ceramic fixed dental restorations; namely crowns. Substructures of DC-Cristall are machined using the DCS Precident CAD/CAM System. The porcelain veneer is applied using dental porcelains currently on the market.
Technological Characteristics: DC-Cristall is a ceramic material that is similar in composition to other ceramic materials that are currently offered in the dental marketplace for the fabrication of single unit crowns.
DC-Cristall is substantially equivalent in concept to predicate devices Substantial Equivalence: (i.e. ceramic materials that are used in the CAD/CAM system) intended for use as the substructure of porcelain fused to ceramic crowns.
The safety and efficacy of DC-Cristall is assured by compliance with ISO 6872:1999 Dental Ceramics.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP = 4 2001
Mr. Ronald Dudek Director of Technical Resources Austenal, Incorporated 4101 West 51st Street Chicago, Illinois 60632-4287
K011674 Re : DC-Cristall Trade/Device Name: 872.6660 Requlation Number: Requlatory Class: II Product Code: EIH Dated: August 23, 2001 Received: August 27, 2001
Dear Mr. Dudek:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marker 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements
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Page 2 - Mr. Dudek
concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Timothy L. Wheatridge
Timo hy A. Ulatowski Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
As Required by CFR 807.87 (e)
K011674 510(k) Number (if known): Device Name: DC-Cristall
Indications For Use:
The indications for use for DC-Cristall is as a substructure for single unit porcelain fused ceramic fixed dental restorations; namely crowns. Substructures of DC-Cristall are machined using the DCS Precident CAD/CAM System.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The Counter Use (Optional format 1-2-96)
Susan Hauser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital I 510(k) Number _
§ 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.