(70 days)
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Not Found
No
The summary describes a dental composite resin material and does not mention any AI or ML capabilities.
No.
The device is a restorative material for dental use (crowns, inlays, onlays) rather than a device intended to treat or prevent disease.
No
Explanation: The device is described as a light-curing polymer for dental restorations (crowns, inlays, onlays, etc.) and repairs. Its intended use is for treatment and restoration, not for diagnosing diseases or conditions.
No
The device description clearly states it is a "light-curing polymer based crown and bridge, inlay, onlay composite resin materials," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the material as a composite resin for dental restorations (crowns, bridges, inlays, onlays, etc.). This is a material used in the body or on the body for structural purposes, not for testing samples outside the body to diagnose or monitor a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, Ceramage is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ceramage is light-curing polymer based crown and bridge, inlay, onlay composite resin materials for anterior and posterior.
CERAMAGE is intended for use for following:
- Used for crown restorations, e.g. jacket crowns and facing crowns for anterior and posterior, inlays, onlays, laminate vehove and apple upper structure of implants.
- Used for extra/intra-oral repair of crown restorations and defect prosthetic restorations.
Product codes
EBF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2005
Mr. David P. Morais Operations Manager ShoFu Dental Corporation 1225 Stone Drive San Marcos, California 92069-4059
Re: K050401
Trade/Device Name: Ceramage Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: February 1, 2005 Received: February 17, 2005
Dear Mr. Morais:
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 approvisions 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 (1 wr 1), it a 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.
1
Page 2 - Mr. Morais
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 moun that 1 Dr mas mas statutes and regulations administered by other Federal agencies. or the Act of ally I outsal the Act's requirements, including, but not limited to: registration 1 ou muse compry William (21 CFR Part 801); good manufacturing practice and noung (= = = = forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as 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), 11 you don't 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 maj count 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,
Suette y. M. Michae. M.D.
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
2
Indications for Use
510(k) Number (if known): 〈〈○5040]
Device Name: Ceramage
Indications For Use:
Ceramage is light-curing polymer based crown and bridge, inlay, onlay composite resin materials for anterior and posterior.
CERAMAGE is intended for use for following:
-
Used for crown restorations, e.g. jacket crowns and facing crowns for anterior and . Osed for Crown restorations, org. Jacksons and upper structure of implants.
ﻢ -
posterior, inlays, onlays, laminate vehove and apple
Used for extra/intra-oral repair of crown restorations and defect prosthetic . restorations.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
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| Division of Anesthesiology, General Hospital, Infection Control. Dental Devices |
5:0(k) Number ________________________________________________________________________________________________________________________________________________________________
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