(49 days)
Core material- when a tooth is fractured a Technique called Post and core is used to restore functum. A post is cemented into the endo dentically Treated tooth. A core material is used to build up around the tooth and post so that a finished appliance can be placed.
Not Found
This appears to be a 510(k) clearance letter from the FDA for a dental core material, not a document describing a study for an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not present in this document.
The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its clearance, and does not involve performance studies against acceptance criteria in the way an AI/ML device would.
Therefore, I cannot provide the requested table and study details.
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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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 1998
Mr. D. Tim Wolf ·Vice President Foremost Dental Manufacturing, Incorporated 242 South Dean Street Englewood, New Jersey 07631
Re : K982201 Zenith LuxaCore Automix Core Material Trade Name: (Multiple) Requlatory Class: I Product Code: EBF Dated: June 22, 1998 Received: June 22, 1998
Dear Mr. Wolf:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Wolf
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
S. Autman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure .... ........
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FDA/ODE/DDIGD
S10(k) Number (if known): K982201
Device Name: Luxe core
Indications For Use:
- Core material-
when a tooth is fractured a Technique called
Post and core is used to restore functum.
A post is cemented into the endo dentically
Treated tooth. A core material is used to
build up around the tooth and post so
that a finished appliance can be placed.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODB)
Susan Rumm
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
escription Use 2er 21 CFR 801.109)
O
O
OR
Over-The-Counter Use
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(Optional Forms! 1-2-96)
§ 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.