(24 days)
Not Found
No
The description focuses on the chemical composition and physical function of the device as a protective film, with no mention of AI or ML technologies.
Yes
The device is described as forming a protective film to ensure the extended release of chlorhexidine onto the teeth and into the saliva, indicating a therapeutic action to deliver a drug.
No
The device forms a protective film on teeth to ensure extended release of chlorhexidine, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a solution containing chemical components (ammonio methacrylate copolymer, triethyl citrate, purified water) intended to form a physical film on teeth. This is a chemical/material-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Prevora Stage 2's Function: Prevora Stage 2 is described as a solution applied directly to the teeth to form a protective film. It acts as a physical barrier and release mechanism for another substance (chlorhexidine).
- No Sample Analysis: The description does not mention any analysis of samples taken from the patient's body. The application is topical and directly on the anatomical site (teeth).
Therefore, Prevora Stage 2 falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Prevora Stage 2, a solution containing 28% (w/w) ammonio methacrylate copolymer Type B USP/NF with 6% (w/w) triethyl citrate USP/NF in purified water USP, is used to form a protective film or coating over a film containing chlorhexidine (i.e. Prevora Stage 1), on the teeth. The methacrylate film temporarily seals and protects the chlorhexidine film thereby ensuring the extended release of the chlorhexidine onto the teeth and into the saliva.
Prevora Stage 2 is to be applied by a licensed dental professional in a dental office, to the full dentition of the patient immediately after Prevora Stage 1 is applied and dried on these same teeth of the patient.
Product codes
LBH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed dental professional in a dental office
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)
Chlorzoin Stage 2, #K944934
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The words "HUMAN SERVICES USA" and "DEPARTMENT OF" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 5 2002
Mr. Ross Perry President CHX Technologies, Incorporated 4800 Dundas Street West, Suite 105 Toronto, Ontario M9A 1B1 CANADA
Re: K023671
Trade/Device Name: Prevora Stage 2 Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: October 30, 2002 Received: November 01, 2002
Dear Mr. Perry:
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.
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 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.
1
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 (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.
This letter will allow you to begin 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 (301) 594-4613. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use
510(k) Number: # K023671
Device Name: Prevora Stage 2
Indications for Use:
Prevora Stage 2, a solution containing 28% (w/w) ammonio methacrylate copolymer Type B USP/NF with 6% (w/w) triethyl citrate USP/NF in purified water USP, is used to form a protective film or coating over a film containing chlorhexidine (i.e. Prevora Stage 1), on the teeth. The methacrylate film temporarily seals and protects the chlorhexidine film thereby ensuring the extended release of the chlorhexidine onto the teeth and into the saliva.
Prevora Stage 2 is to be applied by a licensed dental professional in a dental office, to the full dentition of the patient immediately after Prevora Stage 1 is applied and dried on these same teeth of the patient.
(Note: This indication for use is the same as approved device Chlorzoin Stage 2, #K944934).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Susa Rump | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K023671 |
| Prescription Use | ✓ | OR | Over-the-Counter Use ________ |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |