(139 days)
Not Found
Not Found
No
The summary describes a material (acrylic resin) used in dental and orthodontic applications, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No
The device is described as "Acrylic Resins" used in the fabrication of dental prosthetics and orthodontic devices. These are materials used in the creation of medical devices, rather than a device itself that provides therapy.
No
The device, Nic Tone Acrylic Resins, is used in the fabrication and repair of dental devices. Its intended use does not involve diagnosing conditions or diseases.
No
The 510(k) summary describes acrylic resins, which are physical materials used in the fabrication of dental devices. There is no mention of 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 fabrication, repair, and rebasing of dental and orthodontic devices. This is a manufacturing and restorative process, not a diagnostic one.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator of whether a device is an IVD.
- Lack of Other IVD Indicators: There is no mention of image processing, AI/ML, input imaging modality, anatomical site (in a diagnostic context), patient age range (for diagnostic purposes), or performance studies related to diagnostic accuracy.
In summary, the intended use clearly places this device in the category of dental materials used for fabrication and repair, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Nic Tone Acrylic Resins are used in the fabrication, repair or rebasing of complete or partial removable dentures, the fabrication of veneer crowns, the fabrication of orthodontic devices, and the fabrication of temporary crowns and bridges.
Product codes
OCL, EBI, EEG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" in a circular arrangement. The eagle is composed of three thick, curved lines that suggest the shape of a bird in flight. The text is in all caps and is evenly spaced around the circle.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Manufacturera Dental Continental c/o Mr. Gary S. Mocnik Gary S. Mocnik & Associates 30001 Golden Hartern #334 Haguna Nyvel, CA 92677
Re: K991577 Trade Name: Nic Tone Acrylic Resins Regulatory Class: II (two) Product Code: OCL, EBI, EEG Dated: August 16, 1999 Received: September 02, 1999
Dear Mr. Mocnik:
This letter corrects our substantially equivalent letter of September 22, 1999.
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 (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.
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. Gary S. Mocnik
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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), please contact the Office of Compliance at (240) 276-0120. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K991577
K991577 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Number (if known):
Nic Tone Acrylic Resins Device Name:
Indication For Use:
Nic Tone Acrylic Resins are used in the fabrication, repair or rebasing of complete or partial removable dentures, the fabrication of veneer crowns, the fabrication of orthodontic devices, and the fabrication of temporary crowns and bridges.
(PI.FASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NE.DED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Suar Kurno | |
|---|---|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K991577 |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| Per 21 CFR 801.109 |
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