(70 days)
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No
The summary describes a light-cured resin material, not a software or system that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or performance studies related to algorithmic performance.
No
The device is a light-cured resin used for fabricating temporary dental restorations, which is a structural or restorative function, not a therapeutic one.
No
Explanation: The device is a resin used to fabricate temporary dental prosthetics. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring medical conditions.
No
The device description clearly states it is a "paste type light cured resin," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to fabricate temporary dental restorations (crowns, bridges, inlays, onlays, veneers). This is a direct application to the patient's body (or a model of it) for a restorative purpose.
- Device Description: It's a light-cured resin, a material used in dental procedures.
- Lack of IVD Characteristics: The description does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a physiological or pathological state.
- Being used in vitro (outside the living body) for diagnostic purposes.
Therefore, GC Revotek LC is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
GC Revotek LC is a paste type light cured resin used to fabricate temporary crowns, bridges and veneers.
Product codes
EBC
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized lines or strokes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2001
Mr. Terry L. Joritz Director, Regulatory Affairs & Quality Control GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K012542
Trade/Device Name: Revotek LC Regulation Number: 872.3770 Regulation Name: Acrylic Resin for Temporary Crown & Bridges Regulatory Class: II Product Code: EBC Dated: August 2, 2001 Received: August 7, 2001
Dear Mr. Joritz:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave roviewed your and have determined the device is substantially equivalent (for the icitications 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 mensiale commerce prior to tray been reclassified in accordance with the provisions of Antondments, or to do roob and Cosmetic Act (Act) that do not require approval of a premarket the rederal I ood, Drag, and Connenay, therefore, market the device, subject to the general approvin applisions of the Act. The general controls provisions of the Act include controls provided or a 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 (I MFF), it may of babyeet is the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device earroo found in the announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not I heast that FDA has made a determination that your device complies with other requirements mean that I Dr mas mass statutes and regulations administered by other Federal agencies.
1
Page 2- Mr. Joritz
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with an the Act 3 requirements and 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Bart 800'; and i and listing (21 CFK Fall 807), laboling (21 CFR resulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and i requirements as set form in the quality systems (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 This letter will anow you to ocgin marketing 'y of substantial equivalence of your device to
510(k) premarket notification. The FDA finding of substition and thus 510(K) premarket notification: The PDF Prints of the 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 101 If you desire specific advice for your &o in vitro diagnostic devices), please contact the and additionally 21 CFR Far 809110 103. Additionally, for questions on the promotion and
Office of Compliance at (301) 594-4613. Additionally, for questions of Compliance a Office of Comphance at (301) 59 + 1021 the Office of Compliance at (301) 594-4639. advortibing of your ar antitled, "Misbranding by reference to premarket Also, prease note the rogulation one one of information on your responsibilities under notification (ZTCFK Part 007.97). Oaks gross and Manufacturers, International and the Act may be obtained from the DPH205-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours!
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| 510(k) Number (if known): | K012542 |
|---|---|
| --------------------------- | --------- |
GC Revotek LC Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
GC Revotek LC is a paste type light cured resin
es and folloing to temperary crowns, bridges: as GC Revotek LC is a paste type ragio bridges as
used to fabricate temporary crowns, bridges as used to fabricate tomportal, and veneers.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Conviurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Formal 1-2-96).
Susan Runne
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number .