(5 days)
This product is indicated for use as a substructure for Porcelain fused to ceramic fixed dental restorations; namely crowns and bridges. Foundation Milling Center Z-Blocks are machined using CAD/CAM technology.
This product is a ceramic block made out of ZrO2 (Zirconia Oxide). There is a metal chuck glued on the end of the block that holds the block into the CAD/CAM machine. The block is milled into cores for teeth and then is fired in an oven to harden the ZrO2. Then the core is layered with ceramic porcelain to make a finished tooth.
The provided text is a 510(k) summary for a dental device called "Foundation Milling Center Z-Blocks." This submission asserts substantial equivalence to a predicate device and does not involve a study demonstrating the device meets specific acceptance criteria in the manner typically seen for algorithm-driven medical devices.
Instead, the submission focuses on the technological characteristics and intended use to establish equivalence. Therefore, many of the requested data points (like sample size, ground truth, MRMC studies, etc.) are not applicable to this type of regulatory submission.
However, based on the provided text, I can extract and infer some information, particularly regarding the equivalence argument.
Here's an attempt to answer your request based on the provided document, noting where information is not present or applicable:
1. A table of acceptance criteria and the reported device performance
For this device, the "acceptance criteria" are implied by the requirements for substantial equivalence to the predicate device. The performance is then deemed "equivalent" if these criteria are met.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as stated by sponsor) |
|---|---|
| Same Intended Use as Predicate Device | "This product is indicated for use as a substructure for porcelain fused to ceramic fixed dental restorations; namely crowns and bridges." This matches the intended use of the legally marketed predicate devices. |
| Same Technological Characteristics as Predicate Device | "The technological characteristics between the predicate and proposed devices are identical. There is no difference in fundamental scientific technology. They are made from the same materials and have the same intended use." |
| No significant differences raising questions about safety and effectiveness | "There are no significant differences between the Foundation Milling Center Z-Blocks and the predicate devices and therefore, the Foundation Milling Center Z-Blocks do not raise any questions regarding safety and effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission relies on an equivalency argument based on material composition, manufacturing process, and intended use, rather than a clinical performance study with a test set.
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)
Not applicable. No clinical or diagnostic data was evaluated for "ground truth" establishment in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication was 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 device is a dental ceramic block, not an AI-driven or diagnostic system that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical dental material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is essentially the well-established performance and safety profile of the predicate device based on its design, materials, and intended use. The new device claims to be identical in these aspects.
8. The sample size for the training set
Not applicable. This device is a dental ceramic block, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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SECTION 5. 510(K) SUMMARY OR 510(K) STATEMENT
| SubmissionCorrespondent: | Emergo Group, Inc.2519 McMullen Booth RoadSuite 510-295Clearwater, Florida 33761Phone: (727) 797-4727Fax: (727) 797-4757Email: igordon@emergogroup.comContact: Ian P. GordonSr. Vice President | AUG 2 1 2006 |
|---|---|---|
| Submission Sponsor: | Foundation Milling Center (FMC)235 Aero DriveBuffalo, NY 14225Phone: (716) 838-3838Fax: (716) 839-8004Email: jacob_oppenheimer@yahoo.comContact: Jacob OppenheimerVice President, Product Development | |
| Date summary prepared: | May 31, 2006 | |
| Device trade name: | Foundation Milling Center Z-Blocks | |
| Device common name: | Z-Blocks | |
| Device classification name: | Porcelain Powder for Clinical Use | |
| Legally marketed devicesto which the device issubstantially equivalent: | K051705, IPS E. MAX CAED/IPS E.MAX ZIRCAD, Ivoclar Vivadent, Inc. | |
| Description of the device: | This product is a ceramic block made out of ZrO2 (Zirconia Oxide). Thereis a metal chuck glued on the end of the block that holds the block into theCAD/CAM machine. The block is milled into cores for teeth and then isfired in an oven to harden the ZrO2. Then the core is layered with ceramicporcelain to make a finished tooth. | |
| Intended use of the device: | This product is indicated for use as a substructure for porcelain fused toceramic fixed dental restorations; namely crowns and bridges. FoundationMilling Center Z-Blocks are machined at the user facility using CAD/CAMtechnology. | |
| Technologicalcharacteristics: | The technological characteristics between the predicate and proposeddevices are identical. There is no difference in fundamental scientifictechnology. They are made from the same materials and have the sameintended use. | |
| Conclusions: | By definition, a device is substantially equivalent when the device has thesame intended use and the same technological characteristics as thepredicate device.There are no significant differences between the Foundation Milling CenterZ-Blocks and the predicate devices and therefore, the Foundation MillingCenter Z-Blocks to not raise any questions regarding safety andeffectiveness.The Foundation Milling Center Z-Blocks, as designed, are as safe andeffective as the predicate device, and the device is determined to besubstantially equivalent to the referenced predicate devices currently onthe market. |
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of a stylized eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 1 2006
Foundation Milling Centre 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: K062389
Trade/Device Name: Z-Block 20/19, Z-Block 40/19, Z-Block 55/19 Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: August 15, 2006 Received: August 16, 2006
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 Eederal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not I least be actived that 1 Da determination that your device complies with other requirements mount that I Driving may Federal statutes and regulations administered by other Federal agencies. or the Act of all , vath all the Act's requirements, including, but not limited to: registration r ou intest compry was 807); labeling (21 CFR Part 801); good manufacturing practice and instills (21 ce real of the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form 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) rms fotor wiffication. The FDA finding of substantial equivalence of your device to a premainer notification - Fedicate 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), 11 you dome of 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 maj Secure 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,
Shi-Jie Li, 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 4. INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Z-Block 20/19, Ż-Block 40/19, Z-Block 55/19
Indications for Use:
This product is indicated for use as a substructure for Porcelain fused to ceramic fixed dental restorations; namely crowns and bridges. Foundation Milling Center Z-Blocks are machined using CAD/CAM technology.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russo
.. Ja CHI) in of Anasihesiology, General Hospital, an Cuntral, Dental Devic
: Number.
Foundation Milling Center
§ 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.