DDS-ZR by CHARLES SCHARF | FDA 510(k) Summary

Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, V (Inlays and Onlays) and as a restorative material intended for veneers, crowns, and bridges

Device Description

DDS-ZR is a Zirconia hybrid ceramic ideally suited for computerized dental machining applications. The dental professional prepares the appropriate tooth, sends a traditionally prepared impression to the lab where the restoration is produced, computer machined, and then returned to the dentist for placement. The dentists practice traditional luting/cementing techniques to permanently place the inlay or onlay. DDS-ZR is an alternative to gold, amalgam, porcelain, or composite filling materials, except that its application more closely resembles gold inlays or porcelain inlays or veneers used in a dental laboratory. The material is radioopaque, for ready visualization.

AI/ML Overview

This document describes a 510(k) premarket notification for a dental restorative material, DDS-ZR, a Zirconia hybrid ceramic. The approval is based on substantial equivalence to predicate devices, not on a study demonstrating device performance against specific acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.

Here's an explanation of why each requested point cannot be fully addressed:

A table of acceptance criteria and the reported device performance:
- The document does not specify quantitative acceptance criteria for device performance (e.g., specific thresholds for strength, durability, wear resistance).
- It also does not report specific performance data for DDS-ZR. The approval is based on the material "Zirconia" having been "repeatedly tested throughout the medical and dental literature and research" and found to be "highly biocompatible," and that the material is "well known to the dental industry." This is a qualitative statement about the material class, not specific performance of the device against predefined criteria.
Sample sized used for the test set and the data provenance:
- No test set for performance evaluation is described. The approval is based on the known properties of Zirconia as a material and its similarity to existing legally marketed devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no specific test set requiring expert ground truth establishment is described.
Adjudication method for the test set:
- Not applicable, as no specific test set requiring expert adjudication is described.
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:
- Not applicable. This is a dental material, not an AI-assisted diagnostic or imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a dental material, not an algorithm or AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this approval is the established knowledge and literature regarding Zirconia's biocompatibility and mechanical properties in dental applications, as well as the substantial equivalence to predicate devices. There isn't a specific "ground truth" derived from a clinical study for this device.
The sample size for the training set:
- Not applicable, as there is no mention of a training set for an algorithm.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set or its ground truth establishment.

Summary based on available information:

The provided text is a 510(k) summary for a dental restorative material (DDS-ZR). The approval is based on "substantial equivalence" to predicate devices and the general understanding of the material (Zirconia) in the dental industry. It focuses on the material's characteristics, intended use, and similarity to existing products rather than presenting data from a dedicated performance study with defined acceptance criteria. Therefore, the requested details regarding acceptance criteria, study design, sample sizes, and expert adjudication are not present in this type of regulatory document.

Summary

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XI. SAFE MEDICAL DEVICES ACT OF 1990 SUMMARY OF SAFETY AND EFFECTIVENESS. October 8, 1998. [Separate Pages]

Submitter: Chris Scharf, DDS Services, 7375 S. Peoria, #105, Englewood, CO 80112

Classification names and numbers: Porcelain powder for clinical use, 76EIH, I. Class II.
Dental restorative material, porcelain powder/blocks Common/Usual name: II.
Proprietary name: DDS-ZR III.
Establishment registration number: In process IV.
These are class II devices, material restoratives, for the Classification: V. Classification:
purpose of computer machining dental restorations (Crowns, Bridges, Inlays, and Onlays) per CFR 872.6660
DDS-ZR is a Zirconia hybrid ceramic ideally suited for Device description: VI. Device description: - DDD DR is oplications. The dental professional prepares the computerized demail macinning "Fraditionally prepared impression to the lab appropriate tooth burroduced, computer machined, and then returned to the where for placement. The dentists practice traditional luting/cementing techniques to permanently place the inlay or onlay. DDS-ZR is an alternative to gold, amalgam, porcelain, or composite filling materials, except that its gold, amargain; porcelain, or vobles gold inlays or porcelain inlays or veneers in application more closery resed in a dental laboratory. The material is radioopaque, for ready visualization.
Similar to devices currently on the market approved Substantial equivalence: VII. Substantial equivalencer.
through the 510K process. DDS-ZR is similar to Cercon K-013230, Cynovad Zirkon K023327, and Denzir K984201.

The 510K "Substantial equivalence" decision-making process (detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

These products have the same intended use, to be luted/cemented permanently 1. into place as inlays, and Onlays.
1. The technological characteristics for this product are similar to those for the I no teentiers and those currently on the market except for differences in prodicals of use. The technological features, although distinct, have the same intended use as the devices listed as equivalent.

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1. Descriptive information provided shows that the material from which DDS-Descriptive information pro Auss of many different kinds of hip EN are made are well colacinely greater forces than in the mouth.
1. Zirconia has been repeatedly tested throughout the medical and dental Zircoma has been repoatedry tential and be highly biocompatible. The nitusity and research has all his summary are traditional materials well known to the dental industry.

(End of Summary)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 2004

Charles Scharf C/O Mr. Chris Scharf FDA Correspondent DDS Services, Incorporated 7375 South Peoria, #105 B-10 Englewood, Colorado 80112

Re: K041645

Trade/Device Name: DDS-ZR Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: June 10, 2004 Received: June 17, 2004

Dear Mr. Scharf:

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. Scharf

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 mean that I Dr man made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal but is requirements, including, but not limited to: registration 1 ou intist compry with and 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 CF Real von), e quality systems (QS) regulation (21 CFR Part 820); and if requirenches as bet form nroduct 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) This loter will and in your finding of substantial equivalence of your device to a premarket notification. - 11 miles 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), If you desire speoffice of Compliance at (301) 594-4613. 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 may obtain 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,

Carls

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

K041645

510(k) Number (if known):_

DDS-ZR Device Name: Indications for Use:

Intended to restore carious lesions or structural defects in teeth. It is
t and and and constitues Charact III. V (Inlays and Onlays) and a Intended to restore callous lesions of Structures and Onlays and as a
intended for use in cavities Classes I, II, V (Inlays and Onlays) and hiddes intended for use in Cavitles Glassoc i, m, o (1) = (1) = (1) = (1) = (1) = )
restorative material intended for veneers, crowns, and bridges

AND/OR Prescription Use ____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chris

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K041645

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Regulation Number and Section

§ 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.