(87 days)
Not Found
Not Found
No
The summary describes a composite material for dental restorations and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is described as an "opaquing composite material" used to cover metal for aesthetic purposes in dental restorations. It does not perform any therapeutic function like treating, preventing, or diagnosing a disease or condition.
No
The device is described as an opaquing composite material used to cover metal for aesthetic purposes, not to diagnose a condition.
No
The device description clearly states it is a "composite material," which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is a "light activated... opaquing composite material, designed for use as a tooth or white colored composite material to cover metal and create more aesthetically pleasing restorations." It's used to mask the appearance of metal in dental implants, abutments, or restorations.
- Device Description: The description reiterates its function as a composite material for covering metal in dental applications.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or treat any disease or condition by examining specimens derived from the human body. IVDs are specifically designed for these purposes.
The device described is a dental material used for aesthetic and restorative purposes within the mouth, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Metal Opaquer is a light activated (photo initiated via free radical polymerization) opaquing composite material, designed for use as a tooth or white colored composite material to cover metal and create more aesthetically pleasing restorations.
Metal Oapquer is a composite material which, when utilized properly, masks the metal appearance of dental implants, abutments or restorations with a tooth colored composite layer. Metal Opaquer is compatible with all other methacrylate based dental materials.
Product codes
EBF, EBD
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
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
Not Found
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.
Not Found
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).
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§ 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 features a stylized eagle or bird-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Chris Kulton Co-Owner Apex Dental Materials, Incorporated 330 Telser Road Lake Zurich, Illinois 60047
JUN. 2 3 2011
Re: K110859
Trade/Device Name: Metal Opaquer Regulation Number: 21 CFR 872,3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF, EBD Dated: March 23, 2011 Received: March 31, 2011
Dear Mr. Kulton:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
' If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Mr. Kulton
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Turner
Anthony D. Watson, B.S., M.S., M.B.A. 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): Device name:
Metal Opaquer
િતા જિલ્લાનું મુખ્યત્વે તે તે જેવાં છે. આ ગામમાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી
Metal Opaquer is a light activated (photo initiated via free radical polymerization) opaquing composite material, designed for use as a tooth or white colored composite material to cover metal and create more aesthetically pleasing restorations.
Metal Oapquer is a composite material which, when utilized properly, masks the metal appearance of dental implants, abutments or restorations with a tooth colored composite layer. Metal Opaquer is compatible with all other methacrylate based dental materials.
Susan Rumas
Division Sign-Off) i vision of Anesthesiology, General Hospital Intection Control, Dental Devices
KIN856 510(k) Number:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRL, Office of Device Evaluation (ODE)
Prescription use X (Per 21 CFR 801.109 OR
CONFIDENTIAL
Over- The- Counter Use
(Optional Format 1-2-96)
510K Submission for Metal Opaquer Apex Dental Materials, 330 Telser Road Lake Zurich, IL 60047
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