(59 days)
No
The description focuses on the material properties and manufacturing process (computerized lathe methods) of a dental restorative material. There is no mention of AI or ML in the intended use, device description, or specific sections for AI/ML information.
No.
The device, Cynovad Zirkon™, is a ceramic material used for fabricating dental prostheses such as crowns, veneers, inlays, and onlays, which are restorative materials. It is not used to treat or cure a disease or condition but rather to restore the structural integrity of teeth.
No
Explanation: The device, Cynovad Zirkon™, is a material used for fabricating dental prostheses such as crowns, veneers, inlays, and onlays. It is a restorative material used to prepare and restore damaged teeth. It does not diagnose conditions but rather provides a physical solution for dental repair.
No
The device description clearly describes a physical ceramic material (zirconium dioxide-yttrium oxide ceramic) that is machined into dental prostheses. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the preparation and fabrication of dental prostheses (crowns, veneers, inlays, onlays, copings, frameworks) and as a restorative material for carious lesions and structural defects in teeth. This is a direct application to the patient's body for structural restoration and replacement.
- Device Description: The description details a material used to create physical dental restorations that are then cemented into the patient's mouth.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Anatomical Site: The anatomical site is "Teeth," which are part of the patient's body, not a sample taken from the body for testing.
- Intended User / Care Setting: The users are dentists and dental laboratories, who are involved in the direct treatment and restoration of teeth.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a material used to create a physical restoration for the teeth.
N/A
Intended Use / Indications for Use
Intended for preparation of crowns, facings, veneers, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish. For fabricating copings and frameworks for inlays, 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
EIH
Device Description
Cynovad Zirkon™ is a zirconium dioxide-yttrium oxide ceramic, 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 or onlay prepared by modern computerized lathe methods and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. Cynovad Zirkon™ inlays are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, except that their application more closely resembles 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)
K984201, K-013230, K-001875, K895901, K884166
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 0 2 2002
XI. 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS. [Separate Pages]
Submitter: Naoum Arai, Cynovad, 9710 Route Transcanadienne, St. Laurent (Quebec) CANADA H4S1V9.
I.Classification Names and numbers: Porcelain powder for clinical use, 76EIH, Class II
II. Common/Usual Name: Dental restorative material, porcelain powder/blocks
III. Proprietary Names: Cynovad Zirkon™
IV. Establishment Registration Number: Foreign, in process
V. Classification: These are Class II devices, used in prosthetic dentistry to produce a hard prosthesis with a glass-like finish and are described in CFR 872.6660.
VI. Device Description: Cynovad Zirkon™ is a zirconium dioxide-yttrium oxide ceramic, 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 or onlay prepared by modern computerized lathe methods and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. Cynovad Zirkon™ inlays are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, except that their application more closely resembles 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.
VII. Substantial Equivalence: Relative to devices currently on the market, cleared by the 510(k) process, Cynovad Zirkon™ is basically identical with, Denzir™ cleared under K984201 and Cercon Base cleared under K-013230, and very similar to "Zirconium Oxide for the DCS Precident CAD/CAM System" cleared in K-001875. It is also equivalent to the older "Vita Cerec Blocks" cleared under K895901. It is similar to "Dicor Ceramic Inlay." cleared by Dentsplv. Intl. under K884166.
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, for the repair of damaged teeth.
-
The technological characteristics for this product are similar to those for the predicate device
1
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 t 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.
-
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" chart was used and appears in Attachment III.
(End of Summary)
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
CYNOVAD C/O Dr. Neal Dunning 8309 Bryant Drive Bethesda, Maryland 20817
Re: K023327
Trade/Device Name: Cynovad Zirkon™ Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: September 25, 2002 Received: October 04, 2002
Dear Dr. Dunning,
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 - Dr. Neal Dunning
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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VIII.1 Indications for Use: [Separate Page]
510(k) Number: 000 KO2 332
Device Name: Cynovad Zirkon™
Indications for use:
Intended for preparation of crowns, facings, veneers, inlays and onlays--to produce a hard prosthesis with a porcelain-like finish.
For fabricating copings and frameworks for inlays, 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.
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Prescription Use
(Per 21 CFR 801.109
OR
5
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number._