Intended for use in CAD/CAM technology to produce copings, bridges, and framework core material usage for fixed prosthodontics. Then veneered with porcelain glass to create final restoration.

Device Description

DLMS-Zirblocks is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is capable of machining by modern methods. The material is designated as TZP (slightly stronger) or TZPA (slightly more translucent). The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or onlay prepared by modern computerized lathe methods, sintered to full density, and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or only in place with standard dental adhesives (luting) materials. The material is radio-opaque, for ready visualization.

AI/ML Overview

The provided documents describe a 510(k) premarket notification for a dental material, DLMS-Zirblocks. This submission focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of evaluating a digital health device or AI algorithm.

Therefore, many of the requested elements (acceptance criteria table, sample size, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable to this type of submission. The "study" here is essentially a declaration and comparison of material properties and intended use.

Here's an breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

This type of information is not provided in the context of this 510(k) submission. The submission is a declaration of substantial equivalence, not a performance study against specific acceptance criteria for a diagnostic or AI device. The "performance" is implicitly assumed to be equivalent to the predicate device based on identical material and intended use.

2. Sample size used for the test set and the data provenance

Not Applicable. This submission does not detail a test set of images or patient data to evaluate an algorithm's performance. It is a material science submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No ground truth establishment by experts is described for a test set in this material submission.

4. Adjudication method for the test set

Not Applicable. No test set or adjudication process is described.

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

Not Applicable. This is a material submission, not an AI or diagnostic imaging device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a material submission, not an AI or algorithm.

7. The type of ground truth used

Not Applicable. No ground truth in the context of clinical or diagnostic performance is used. The "truth" being established is the equivalence of the material properties and intended use to the predicate device.

8. The sample size for the training set

Not Applicable. There is no training set mentioned as this is not an AI/algorithm submission.

9. How the ground truth for the training set was established

Not Applicable. There is no training set mentioned.

Summary of the 510(k) Submission's Approach to "Acceptance Criteria" and "Study":

The "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to a legally marketed predicate device. The "study" or evidence provided to meet these criteria is primarily through direct comparison and declaration of identical material composition and intended use.

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence):
- The device must have the same intended use as the predicate device.
- The device must have the same technological characteristics as the predicate device.
- If there are differences in technological characteristics, those differences must not raise new questions of safety and effectiveness.
- The device must be as safe and effective as the predicate device.
Reported Device "Performance" (as per the submission):
- Intended Use: Identical to the predicate device (Metoxit CAM-Blanks) - "Intended for use in CAD/CAM technology to produce copings, bridges, and framework core material usage for fixed prosthodontics. Then veneered with porcelain glass to create final restoration."
- Material Composition: Identical to the predicate device - "partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder."
- Technological Characteristics: Declared as "identical." "There is no difference in fundamental technology. They have the same intended use and are made from the same materials."
- Safety and Effectiveness: Concluded to be "equally safe and effective" due to the identical nature to the predicate device.

In essence, the entire 510(k) document serves as the "study" by asserting that the DLMS-Zirblocks are fundamentally the same as the predicate device, Metoxit CAM-Blanks, and therefore meet the implicit safety and effectiveness criteria by virtue of that equivalence.

Summary

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Rosal37

DLMS 14201 N. 87ª Street, Suite A-105 Scottsdale, AZ 85260

・・

Section G

FEB 1 0 2009

and the comments of the count

510(k) Summary

510(k) Summary	This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92
Applicant	Dental Laboratory Milling Supplies (DLMS)14201 N. 87th Street, Suite A-105Scottsdale, AZ 85260
Contact Person	Name and Title: Scott Atkin, Founder DLMSPh: 480-948-0466Fax: 480-443-7666
Date Prepared	25 JUL 2008
Trade Name	DLMS-Zirblocks
Classification Name	Porcelain Powder for Clinical Use
Common Name	CAM-Blanks
Predicate Devices	Legally marketed device to which we claim equivalence: Metoxit CAM-Blanks, Metoxit AG, K072569
Description	DLMS-Zirblocks is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is capable of machining by modern methods. The material is designated as TZP (slightly stronger) or TZPA (slightly more translucent). The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or onlay prepared by modern computerized lathe methods, sintered to full density, and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or only in place with standard dental adhesives (luting) materials. The material is radio-opaque, for ready visualization.
Indications for Use	Intended for use in CAD/CAM technology to produce copings, bridges, and framework core material usage for fixed prosthodontics. Then veneered with porcelain glass to create final restoration.
TechnologicalCharacteristics	The technological characteristics between the predicate devices and the proposed device are identical. There is no difference in fundamental technology. They have the same intended use and are made from the same materials.
SubstantialEquivalence	The product is the exact same material used for the predicate device, the Metoxit CAM-Blanks, and is equivalent in function and intended use to the predicate device.
Conclusion	There are no significant differences between the DLMS-Zirblocks and the predicate device, the Metoxit CAM-Blanks, and therefore, the DLMS-Zirblocks are equally safe and effective

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dental Laboratory Milling Supplies Mr. Scott Atkin 14201 North 87th Street Suite A-105 Scottsdale, Arizona 85260

FEB 1 0 2009

Re: K082137

Trade/Device Name: DLMS-Zirblocks Regulation Number: 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: II Product Code: EIH Dated: February 4, 2009 Received: February 5, 2009

Dear Mr. Atkin:

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. Atkin

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Sutie Y. Michael Davis.

Ginette Y. Michaud, M.D. Acting 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): _KORA)3

Device Name: DLMS-Zirblocks

Indications for Use:

Intended for use in CAD/CAM technology to produce copings, bridges, and framework core material usage for fixed prosthodontics. Then veneered with porcelain glass to create final restoration.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Page 1 of 1

Suna Reaser

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

510(k) Number: K082137

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.