(39 days)
No
The summary describes a ceramic material for dental restorations and the process of using it, with no mention of AI or ML technologies.
No
The device is a material for fabricating dental prostheses, not a device directly used for therapy or treatment.
No
The device description indicates that Sagemax Z-Blank™ is a material used for fabricating dental prostheses (crowns, facings, inlays, onlays) in a dental laboratory, which are then cemented into place by a dentist. This describes a restorative material, not a device used to diagnose medical conditions or diseases.
No
The device description clearly describes a physical ceramic material (zirconium dioxide-yttrium oxide ceramic) used for fabricating dental prostheses, which is a hardware component.
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 structural defects in teeth. This is a restorative dental device, not a diagnostic test performed on biological samples.
- Device Description: The device is a ceramic material used to fabricate dental prostheses in a dental laboratory. It is then cemented into the patient's mouth. This process is a treatment or restoration, not a diagnostic procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
Therefore, the Sagemax Z-Blank™ is a dental restorative material, 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. The suitability of high purity dense yttria tetragonal zirconium oxide has been well demonstrated for many uses in the dental industry
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
Sagemax Z-Blank™ 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 prepares the final tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. Sagemax Z-Blank "" 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-opague, 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)
K050903, K043472, K023227, 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.
0
XI.
510 (k) SUMMARY
OCT 2 0 2006
Submitter: Larry Dang, Sagemax Bioceramics, Inc. 11061 NE 200 St., Bellvue, WA 98004.
l. 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: Sagemax Z-Blank™M
IV. Establishment Registration Number: In process
V. Device Description: Sagemax Z-Blank™ 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 prepares the final tooth surfaces involved and cements (lutes) the inlay or onlay in place with standard dental adhesives (luting) materials. Sagemax Z-Blank "" 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-opague, for ready visualization.
VI. Substantial Equivalence: Sagemax Z-Blank™ (when it reaches the dentist, like porcelain "powder" prepared by the laboratory into an inlay 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, Sagemax Z-Blank is substantially equivalent to Xavex cleared in K050903, to Medin Tech Zirconia CP10, 1000™ cleared in K043472, and to Cynovad Zirkon cleared in K023227 and equivalent to Denzir™ (Dentronic AB) cleared under K984201 as well as Cercon Base™ (Degussa Dental) cleared under K-013230. Like Cercon Base, 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 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 Sagemax Z-Blank™ product in legally marketed devices, the similarity of the formulations used in this device and earlier devices, and the substantially equivalence of Sagemax Z-Blank to prior cleared devices support the safety and effectiveness of the Sagemax Z-Blank™ product for the intended use.
1
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 2. The technological ohose currently on the market except for slight differences in predicate donood and the technological differences are well understood in the mothous of too. The use of a computerized lathe system to prepare the inlay on 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 o. Bookport well-established in the more demanding areas of hip implants. They made "are" won obtablished porcelain products and usually will have porcelain finishes.
imishoo:
4. The FDA "Decision-Making Process" chart was used and appears in Attachment V.
[End of Summary]
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Larry Dang President Sagemax Bioceramics, Incorporated 11061 NE 2nd Street, Suite 168 Bellevue, Washington 98004
OCT 2 0 2006
Re: K062695
Trade/Device Name: Sagemax Z-Blank™ Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: August 29, 2006 Received: September 11, 2006
Dear Mr. Dang:
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 - Mr. Larry Dang
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 (OS) 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" (21 CFR 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,
Clives
Chiu S. Lin, PhD 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]
1667695
510(k) Number: NA
Device Name: Sagemax Z-Blank™
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. The suitability of high purity dense yttria tetragonal zirconium oxide has been well demonstrated for many uses in the dental industry
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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | |
| Number: | K062695 |