(81 days)
No
The description focuses on the material properties and manufacturing process (computerized lathe methods) of the dental prosthesis, with no mention of AI or ML for design, analysis, or other functions.
No
The device is described as a material used to prepare crowns, facings, inlays, and onlays, and to restore carious lesions or structural defects in teeth. It functions as a prosthetic material for dental restoration, rather than directly treating or curing a disease or condition.
No
Explanation: The device is a material (yttrium oxide-stabilized zirconia) used for fabricating dental prostheses such as crowns, inlays, and onlays, and for restoring carious lesions. Its intended use is to create a physical restoration, not to diagnose a condition or disease.
No
The device description clearly describes a physical material (yttrium oxide-stabilized zirconia) used to fabricate dental prostheses, which is a hardware component. The process involves scanning impressions and using computerized lathe methods, but the core device being cleared is the material itself and the resulting physical prosthesis.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The device described is a material (yttrium oxide-stabilized zirconia) used to fabricate dental prostheses (crowns, inlays, onlays, etc.). These prostheses are then placed in the patient's mouth to restore teeth.
- Lack of Biological Sample Testing: The description does not mention the device being used to test any biological samples from the patient. Its function is purely for the creation of a physical dental restoration.
The device is a dental restorative material used in the fabrication of prostheses, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
Intended for use in preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations.
Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Zirl3lank-PS and ZirBlank-FS is a yttrium oxide-stabilized zirconia (Y-ITZP) capable of machining by modern methods. 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, onlay or other prosthesis is prepared by modern computerized lathe methods and returned to the dentist. The dentist then prepares the final tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. ZirBlank-PS and ZirBlank-FS prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opaque, for ready visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist, dental laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K061804, K050903, K043472, K023327, K984201, K-013230
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
XI.
510 (k) SUMMARY
Submitter: Dr. Kyung-Bin Lee, Pres. Acucera, Inc., Namyangiu-si, Gyeonggi 472-481, (Seoul) Korea. Phone: 82-(0)31-527-6940.
- I. Classification Names and numbers: Porcelain powler for clinical use, EIH, Class II, described in CFR 872.6660.
- II. Common/Usual Name: Dental restorative material, porcelain powder/blocks
III. Proprietary Names: ZirBlank-PS and ZirBlank-FS
1070045
IV. Establishment Registration Number: In process
V. Device Description: Zirl3lank-PS and ZirBlank-FS is a yttrium oxide-stabilized zirconia (Y-ITZP) capable of machining by modern methods. 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, onlay or other prosthesis is prepared by modern computerized lathe methods and returned to the dentist. The dentist then prepares the final tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. ZirBlank-PS and ZirBlank-FS prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcelain inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-opaque, for ready visualization.
VI. Substantial Equivalence: ZirBlank-PS and ZirBlank-FS (when it reaches the dentist, like porcelain "powder" prepared by the laboratory into an inlay or onlay, or as a bridge or crown) is a finished device ready for installation. Relative to devices currently on the market, cleared by the 510(k) process, ZirBlank-PS and ZirBlank-FS is substantially equivalent to Zerion Alpha; Zerion Beta, cleared in K061804, to Xavex cleared in K050903, to Medin Tech Zirconia CP10, 1000 M cleared in K043472, and to Cynovad Zirkon cleared in K023327 and equivalent to Denzir"11 (Dentronic AB) cleared under K984201 as well as Cercon Base™ (Degussa Dental) cleared under K-013230. Like Zerion Alpha & Beta, it is intended to be marketed both as a partially sintered device which will then be machined and fully sintered and in a fully sintered form. Like Austenal's DC Zirkon (001815) it can be used in the DCS CAD/CAM system, and in the CNC milling machine, or other CAD/CAM system meeting the requirements of the recently issued FDA Class II Special Controls Guidance for Optical Impression System... for Dental Restorations.
The successful prior use of the components of ZirBlank-PS and ZirBlank-FS product in legally marketed devices, the similarity of the formulations used in this device and earlier devices, and the substantially equivalence of ZirBlank-PS and ZirBlank-FS to prior cleared devices support the safety and effectiveness of the ZirBlank-PS and ZirElank-FS product for the intended use.
The "510(k) "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 cemented/luted into place as inlays, onlays, veneers or crowns and for bridge components the repair of damaged teeth.
7
- These products have the same intended use, to be cemented/luted into place as inlays, onlays, veneers or crowns and for bridge components the repair of damaged teeth.
1
-
- The technological characteristics for this product are similar to those for the predicate devices and those currently on the market except for slight differences in methods of use. In addition, the technological differences are well understood in the dental industry. The use of a computerized lathe system to prepare the inlay or only, when used in the dental office, also has been cleared by 510(k)--K950299 and K972276 and others.
-
- Descriptive information provided shows that the materials from which this device is made are well-established in the more demanding areas of hip implants. They resemble the properties of finished porcelain products and usually will have porcelain finishes.
-
- The FDA "Decision-Making Process" char: was used and appears in Appendix V.
[End of Summary]
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with its wings spread, rendered in a simple, bold line drawing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dr. Kyung- Bin Lee President Acucera, Incorporated 539 Jinbul-Li Jinjeop, Namyangju Gyeonggi, Republic of Korea 472-861
MAR 2 6 2007
Re: K070045
Trade/Device Name: ZirBlank- PS and ZirBlank-FS Regulation Number: 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 14, 2006 Received: January 4, 2007
Dear Dr. Bin Lee:
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.
3
Page 2 - Dr. Bin Lee
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 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 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/industry/support/index.html.
Sincerely vours.
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
4
VIII. Indications for Use: [Separate Page]
510(k) Number: NA
Device Name: ZirBlank-PS and ZirBlank-FS
Indications for use:
Intended for use in preparation of crowns, facings, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. Frequently used with porcelain overlay for translucence and related effects. For fabricating copings and frameworks for inlays, onlays, veneers, crowns, anterior and posterior bridge restorations.
Intended to restore carious lesions or structural defects in teeth. It is intended for use in cavities Classes I, II, and V (inlays and onlays) and as a restorative material intended for veneers, crowns and bridges.
Prescription Use X (Per 21 CFR 801 Subpart D ) OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE--- CONTINUE ON ANOTHER PAGE IF NEEDE!
Concurrence of CDRH, Office of Device Evaluation(ODE)
Susan Runse
f Anesthesia, Department of Anesthesia, General Hospital Hospital
Infection Control, Central Services
Neart Ko20045