(48 days)
No
The device description focuses on the material composition and manufacturing process of dental prostheses, with no mention of AI or ML for analysis, design, or manufacturing control. The process described is traditional dental laboratory work involving scanning and computerized lathe methods, which are not inherently AI/ML.
No.
The device is a material (zirconium dioxide-yttrium oxide ceramic block) used to fabricate dental prostheses (crowns, facings, inlays, onlays, veneers, bridges) to restore teeth. It is not an active therapeutic device that directly treats or provides therapy to a patient.
No
The device is a restorative material used for preparing crowns, facings, inlays, and onlays, and for filling carious lesions or structural defects in teeth. It does not perform any diagnostic function.
No
The device description clearly states it is a ceramic block material used to fabricate physical dental prostheses, which are hardware components.
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 of dental prostheses (crowns, facings, inlays, onlays, veneers, bridges) to restore teeth. This is a direct restorative and prosthetic application within the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a material (zirconium dioxide-yttrium oxide ceramic block) that is machined into a finished prosthesis for placement in the mouth. It is described as an alternative to other dental filling and prosthetic materials.
- Lack of IVD Characteristics: There is no mention of the device being used to test a sample (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's health status. The process described is the fabrication and placement of a dental restoration.
Therefore, the PSL BioZir Block™ is a dental restorative material and prosthesis, not an in vitro diagnostic device.
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
EIH
Device Description
PSL BioZir Block™ is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern methods. PSL BioZir Block™ (when it reaches the dentist, like opercelain "powder" prepared by the laboratory into an inlay or onlay, or as a bridge or crown) is a finished device ready for installation. 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 crown inprepsived or modern computerized lathe methods and returned to the dentist then prepares the final tooth surfaces involved and cements (lutes) the prosthesis in place with standard departs adle timal (luting) materials. PSL BioZir Block™ prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcely inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-onage, 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
Dental laboratory, dental office
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)
K-S26(S), K050903, K043472, K023327, K984201, K-013230
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.
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510 (k) SUMMARY
FEB - 6 2000
Submitter: Catherine Feng, PSL International, Inc. 1424 Hymus, City of Dorval, Quebec, HpP 1J6, Canada.
I. Classification Names and numbers: Porcelain powder for clinical use, EIH, Class II, described in CFR 872,6660.
II. Common/Usual Name: Dental restorative material, porcelain powder/blocks
III. Proprietary Names: PSL BioZir Block-TM
IV. Establishment Registration Number: In process
V. Device Description: PSL BioZir Block™ is a zirconium dioxide-yttrium oxide ceramic, capable of machining by modern methods. PSL BioZir Block™ (when it reaches the dentist, like opercelain "powder" prepared by the laboratory into an inlay or onlay, or as a bridge or crown) is a finished device ready for installation. 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 crown inprepsived or modern computerized lathe methods and returned to the dentist then prepares the final tooth surfaces involved and cements (lutes) the prosthesis in place with standard departs adle timal (luting) materials. PSL BioZir Block™ prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcely inlays, onlays or veneers in that they are actually prepared in a dental laboratory. The material is radio-onage, for ready visualization.
VI. Substantial Equivalence: Relative to devices currently on the market, cleared by the 510(k) process, PSL International, Inc. is substantially equivalent to Sagemax Z-Blank, cleared in IN-S26(S), to Xavex cleared in K050903, to Medin Tech Zirconia CP10, 1000™ cleared in K043472, and to Cynovad Zirkon cleared in K023327 and equivalent to Denzir" (Dentronic AB) cleared under K984201 as well as Cercon Base™ (Degussa Dental) cleared under K-013230.
Like Sagemax Z-blank, it is intended to be marketed as a partially sintered device which will then be machined and fully sintered. Like Austenal's DC Zirkon (001815) it can be used in the DSS 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 Ironpression System ... for Dental Restorations.
The successful prior use of the components of PSL BioZir Block™ product in legally marketed devices, the similarity of the formulations used in this device and earlier devices, and the ubantantial equivalence of PSL BioZir Block" to prior 510(k) cleared devices support the safety and effectiveness of the PSL International, Inc. M product for the intended use.
XI.
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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.
-
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 were 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.
[End of Summary]
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
FEB - 6 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Catherine Feng President P.S.L. International, Incorporated 1424 Hymus, Suite 15 Dorval, Quebec H9P 116 CANADA
Re: K073568
Trade/Device Name: PSL BioZir Block™ Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 11, 2007 Received: December 20, 2007
Dear Ms. Feng:
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- Ms. Feng
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 yours.
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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VIII. Indications for Use: [Separate Page]
KO73568 510(k) Number: NA
Device Name: PSL BioZir Block™
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 (Per 21 CFR 801.Subpart D )
OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation(ODE) | |
|---|---|
| Susan Rasor | |
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K073568 |
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