(49 days)
Not Found
Not Found
No
The summary describes a dental cement and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is a luting cement used for the cementation of dental restorations, which is a material used in a restorative process, not a therapeutic treatment.
No
The device is described as a permanent luting cement used for the cementation of dental restorations, which is a treatment or restorative function, not a diagnostic one.
No
The device is described as a "compomer based permanent luting cement," which is a physical material used in dentistry, 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 device as a "permanent luting cement to be applied by the dental professional prior to the cementation of crowns, bridges, inlays, onlays and veneers in patients." This is a material used in vivo (within the body) for a dental procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of bodily fluids, or diagnostic purposes.
Therefore, PermaCem® is a dental material used for cementation, not an IVD.
N/A
Intended Use / Indications for Use
PermaCem® is a compomer based permanent luting cement to be applied by the dental professional prior to the cementation of crowns, bridges, inlays, onlays and veneers in patients.
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
Not Found
Intended User / Care Setting
dental professional
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)
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 contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other, with "Public" on the top line, "Health" on the second line, and "Service" on the third line.
DEPARTMENT OF HEALTH & HUMAN SERVICES • USA
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 0 1998
Foremost Dental Manufacturing, Incorporated ·C/O Ms. An-Shih Cheng Cheng & Associates, Incorporated 415 West Aldine Avenue #10-A Chicago, Illinois 60657
Re : K981813 PermaCem® Automix Luting Cement System Trade Name: Requlatory Class: II Product Code: EBF Dated: May 21, 1998 Received: May 22, 1998
Dear Ms. An-Shih Cheng:
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 against 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Ms. An-Shih Cheng
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 regulation 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,
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page__1___of___1__
510(k) Number (if
known):
K981813
PermaCem® Automix luting cement system Device Name:
PermaCem® is a compomer based perma-Indications for Use: nent luting cement to be applied by the dental professional prior to the cementation of crowns, bridges, inlays, onlays and veneers in patients.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) wwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwwww
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runno
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number L981813.
Prescription Use Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ X OR (Per 21 CFR 801.109)
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