(84 days)
Not Found
No
The device description and intended use are for a fluoride varnish, a chemical substance applied to teeth, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the "treatment of hypersensitive teeth," which directly addresses a health condition.
No
The device is intended for treatment and sealing, not for diagnosing conditions.
No
The device description clearly states it is a "FLUORIDE VARNISH" which is a physical substance applied to teeth, not a software program.
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.
- Device Function: The description clearly states that the device is a "FLUORIDE VARNISH" applied to the surface of teeth for treatment and sealing purposes. It does not involve testing samples taken from the body.
- Intended Use: The intended uses are therapeutic (treating hypersensitivity) and protective (sealing dentinal tubules, cavity liner). These are not diagnostic functions.
Therefore, this device falls under the category of a dental therapeutic or restorative material, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Intended for: 1) treatment of hypersensitive teeth: 2) sealing the dentinal tubu es for cavity preparations or on sensitive root surfaces; and 3) a cavity liner.
- Treatment of hypersensitive teeth e
- () Sealing of dentinal tubules for cavity preparations or on sensitive root surfaces
- Cavity liner t)
Product codes
LBH
Device Description
FLUORIDE VARNISH coats a prepared tooth surface prior to placement of any restorative materials to prevent any of the restorative materials from pene rating into the dentinal tissue. FLUORIDE VARNISH contains releasable fluoride.
FLUORIDE VARNISH will be offered in unit dose vials with applicator brushes. Each vial contins material to treat 4-8 teeth, depending on their size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth, dentinal tubules, root surfaces
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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.
0
Image /page/0/Picture/0 description: The image shows a close-up of a dark, textured area contrasted against a bright white space. The dark area appears to be a solid mass with an uneven, grainy texture. A curved line separates the dark area from the white space, suggesting a boundary or edge. The composition focuses on the contrast between the textures and tones.
SEP 1 5 2003
510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
NTSPLY Internationa 70 West College Avenue .O. Box 872 York, PA 17405-0872 717| 845-7511 ww.dentsplv.com
Ko 31932
P. J. Lehn Telefax (717) 849-4343
| CONTACT: | P. Jeffery Lehn | |
|---|---|---|
| DATE PREPARED: | June 19, 2003 | |
| TRADE OR PROPRIETARY NAME: | FLUORIDE VARNISH | |
| CLASSIFICATION NAME: | Cavity Varnish | 872.3260 |
| PRE DICATE DEVICES: | Duraphat Fluoride Varnish | K945794 |
| Duragard Fluoride Varnish | K002581 |
DEVICE DESCRIPTION: FLUORIDE VARNISH coats a prepared tooth surface prior to placement of any restorative materials to prevent any of the restorative materials from pene rating into the dentinal tissue. FLUORIDE VARNISH contains releasable fluoride.
FLUORIDE VARNISH will be offered in unit dose vials with applicator brushes. Each vial contins material to treat 4-8 teeth, depending on their size.
INTENDED USE: Intended for: 1) treatment of hypersensitive teeth: 2) sealing the dentinal tubu es for cavity preparations or on sensitive root surfaces; and 3) a cavity liner.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in FLUORIDE VAF NISH have been used in legally marketed devices or were found safe for dental use.
FLUORIDE VARNISH has been evaluated and passed biocompatibility testing for cytotoxicity, acut : oral toxicity, irritation, and sensitization.
We selieve that the prior use of the components of FLUORIDE VARNISH in legally marketed predicate devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of FLUORIDE VARNISH for the indicated uses.
11 - 12.04
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Public Health Service
SEP 1 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re: K031932
Trade/Device Name: Fluoride Varnish Regulation Number: 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: June 19, 2003 . Received: June 23, 2003
Dear Mr. Lehn:
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.
2
Page 2 - Mr. Lehn
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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known): 4503 (932
FLUORIDE VARNISH Device Name:
Indications for Use:
- Treatment of hypersensitive teeth e
- () Sealing of dentinal tubules for cavity preparations or on sensitive root surfaces
- Cavity liner t)
Kein Mulay for MSA
on of Anesthesiology. General Hospital, Infection Control, Dental Devices
510(k) Number:_
(PI.EASE: DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
I rescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)