(87 days)
Bisque Zirconia Blanks, Type BYZ are indicated for use as a substructure for ceramic dental restorations. All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.
Zircar Zirconia Blanks, Type BYZ, are high purity, bisque fired zirconia machining blanks. The powders pressed to form these blanks are of a uniform size and well dispersed, ensuring no agglomerates. The resultant fine grained, bisque body allows intricate shapes to be machined with tight tolerances. BYZ blanks are phase stabilized with 3 mol% yttria and therefore do not undergo the usual phase transitions associated with pure zirconia. This phase transformation "toughens" the zirconia and stops crack propagation, yielding high fracture toughness and high strength. The highest purity powders are used to make Type BYZ minimizing trace oxides. Type BYZ is 99.9 wt% ZrO2 + Y203 + HfO2 + Al2O3. The natural zirconia minerals HfO2, which is so similar in structure and chemical properties to zirconia, that it has no effect on product properties. A small addition of alumina minimizes hydrothermal aging. Zircar Zirconia Blanks, Type BYZ, are dental ceramic blanks designed for the manufacturing of substructures for ceramic dental appliances. The dental appliance is machined either by CAD/CAM machining or using the copying technique. Products are either porous or dense. Porous blanks are then sintered to full density and strength. Dense blanks do not need a final heat treatment and are therefore ready for veneering immediately after machining. All appliances are for the sole use of the particular patient only. At the dental lab, a metal chuck is glued on the end of blank that holds it in the CAD/CAM machine which is used to machine the final dental restoration. At he completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2.
The provided text is a 510(k) summary for a dental device (Bisque Zirconia Blanks, Type BYZ) seeking substantial equivalence to predicate devices. This type of submission relies on demonstrating that the new device has the same intended use and similar technological characteristics, or if different, that it is as safe and effective and does not raise new questions of safety and effectiveness.
Therefore, the study design elements typically associated with AI/ML-driven medical devices (such as clinical trials with detailed acceptance criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance) are not applicable to this 510(k) submission.
The document states: "By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics. But, it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device."
It concludes: "As such, it has been shown in this 510(k) submission, that the differences between the Bisque Zirconia Blanks, Type BYZ and the predicate devices do not raise any questions regarding their safety and effectiveness."
Answer based on the provided text:
This 510(k) submission is for Bisque Zirconia Blanks, Type BYZ, which are dental ceramic blanks. The submission is based on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a traditional clinical study with detailed performance metrics.
Therefore, the following information is not provided or not applicable in this 510(k) summary:
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A table of acceptance criteria and the reported device performance: Not applicable. The submission asserts substantial equivalence based on intended use and technological characteristics being similar to predicate devices, or if different, that safety and effectiveness are equivalent and no new questions are raised. No specific performance metrics or acceptance criteria are presented for the device in the provided text.
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Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set data is described.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No expert-established ground truth for a test set is described.
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Adjudication method for the test set: Not applicable. No test set requiring adjudication is described.
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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 not an AI-driven diagnostic tool, and no MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a material for dental restorations, not an algorithm.
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The type of ground truth used: Not applicable. No ground truth is established as no clinical study with performance metrics is described.
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The sample size for the training set: Not applicable. There is no algorithm, and therefore no training set.
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How the ground truth for the training set was established: Not applicable. There is no algorithm, and therefore no training set.
The submission focuses on the intended use (substructure for ceramic dental restorations) and technological characteristics (high purity, bisque fired zirconia machining blanks, phase stabilized with 3 mol% yttria, 99.9 wt% ZrO2 + Y2O3 + HfO2 + Al2O3) to argue for substantial equivalence to the predicate devices:
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SECTION 5 - 510(k) SUMMARY
SEP 2 5 2008 Submission Correspondent: Emergo Group, Inc. Address: 1705 S. Capital of Texas Hwy Suite 500 Austin, TX 78746 Phone: (512) 327-9997 Fax: (512) 327-9998 Contact: Stuart R. Goldman Submission Sponsor: Zircar Zirconia, Inc. PO Box 287 Florida, NY 10921-0287 Tel: 845.651.3040 Fax: 845.651.0074 www.zircarzirconia.com May 30, 2008 Date Prepared: Bisque Zirconia Blanks, Type BYZ Trade Name : Common/Usual Name: Porcelain Powder Blocks for Dental Restorations Classification Name: Porcelain Powder for Clinical Use Classification Number: 872.6660 Classification Panel: Dental Devices CDRH Product Code: EIH Regulatory Class: II Device Description: Zircar Zirconia Blanks, Type BYZ, are high purity, bisque fired zirconia machining blanks. The powders pressed to form these blanks are of a uniform size and well dispersed, ensuring no agglomerates. The resultant fine grained, bisque
body allows intricate shapes to be machined with tight tolerances. BYZ blanks are phase stabilized
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with 3 mol% yttria and therefore do not undergo the usual phase transitions associated with pure zirconia. This phase transformation "toughens" the zirconia and stops crack propagation, yielding high fracture toughness and high strength. The highest purity powders are used to make Type BYZ minimizing trace oxides. Type BYZ is 99.9 wt% ZrO2 + Y203 + HfO2 + Al2O3. The natural zirconia minerals HfO2, which is so similar in structure and chemical properties to zirconia, that it has no effect on product properties. A small addition of alumina minimizes hydrothermal aging.
Zircar Zirconia Blanks, Type BYZ, are dental ceramic blanks designed for the manufacturing of substructures for ceramic dental appliances. The dental appliance is machined either by CAD/CAM machining or using the copying technique. Products are either porous or dense. Porous blanks are then sintered to full density and strength. Dense blanks do not need a final heat treatment and are therefore ready for veneering immediately after machining. All appliances are for the sole use of the particular patient only. At the dental lab, a metal chuck is glued on the end of blank that holds it in the CAD/CAM machine which is used to machine the final dental restoration. At he completion of the machining steps, the dental restoration is fired (i.e., sintered) in the oven to harden the ZrO2.
| Intended Use: | Bisque Zirconia Blanks, Type BYZare indicated for use as a substructure for ceramicdental restorations. |
|---|---|
| All blanks are solely by or on the order of adental professional. They are not for use by thegeneral public or over-the-counter. |
Safety and Effectiveness:
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different
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technological characteristics. But, it can be demonstrated that the device is as safe and effective as the predicate device and the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.
As such, it has been shown in this 510(k) submission, that the differences between the Bisque Zirconia Blanks, Type BYZ and the predicate devices do not raise any questions regarding their safety and effectiveness.
The Bisque Zirconia Blanks, Type BYZ, as designed and manufactured are as safe and effective as the predicate device and therefore are determined to be substantially equivalent to the referenced predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is depicted in black, and the text is also in black against a white background. The overall design is simple and conveys a sense of official government authority.
SEP 2 5 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zircar Zirconia, Incorporated C/o Mr. Stuart R. Goldman Senior Consultant Emergo Group, Incorporated 1705 South Capital of Texas Highway, Suite 500 Austin, Texas 78746
Re: K081850
Trade/Device Name: Bisque Zirconia Blanks Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Il Product Code: EIH Dated: June 11, 2008 Received: July 2, 2008
Dear Mr. Goldman:
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. Goldman
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); labcling (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 vours.
TK. Arnolds fund mo
form
Chiu S. Lin, Ph. D Division 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): ____________________________________________________________________________________________________________________________________________________
Device Name:
Bisque Zirconia Blanks
Type: BYZ
Sizes:
15mmx 20mm x 15mm TK 19mm x 40mm x 15mm TK 54mm x 103mm 15mm TK 9mm x 55mm x 15mm TK 25mm x 65mm x 22mm TK 25mm x 62mm x 15mm TK 25mm x 57mm x 15mm TK
Indications for Use:
Bisque Zirconia Blanks, Type BYZ are indicated for use as a substructure for ceramic dental restorations.
All blanks are solely by or on the order of a dental professional. They are not for use by the general public or over-the-counter.
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 Punner
Page of
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
081850
§ 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.