Tray, Fluoride, Disposable
A Disposable Fluoride Tray is a single-use dental device used to apply topical fluoride treatments to the teeth, holding fluoride gel or foam in contact with tooth surfaces during preventive dental procedures to reduce the risk of cavities. It is classified as FDA Class 1, indicating low risk subject to general controls with no premarket clearance required. The product code is KMT and the applicable regulation is 21 CFR 872.6870 in the Dental specialty. This device is GMP exempt.
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Basic Information
- Product Code
- KMT
- Device Class
- FDA class 1
- Regulation Number
- 872.6870
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K031809 | PERIO PROTECT TRAY | Jan 23, 2004 | Substantially Equivalent | Perio Protect, LLC |
| K904914 | DENTAL VACUUM INJECTION TRAY | Dec 17, 1990 | Substantially Equivalent | The Lebanon Vac-Tray Corp. |
| K871784 | TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI | May 27, 1987 | Substantially Equivalent | Colgate-Hoyt Laboratories |
| K853882 | SUPER SLICK | Nov 18, 1985 | Substantially Equivalent | Tang Products |
| K820104 | NUPRO* GEL TRAY | Feb 23, 1982 | Substantially Equivalent | Johnson & Johnson Professionals, Inc. |
| K811154 | HOYT ECONO-TRAY | May 13, 1981 | Substantially Equivalent | Hoyt Laboratories |
| K780712 | KERR DISCOVERY DISPOSABLE FLUORIDE TRAY | May 17, 1978 | Substantially Equivalent | Kerr Corporation (Danbury) |
| K770064 | FLUORIDE GEL DISPOSABLE TRAY | Jan 14, 1977 | Substantially Equivalent | Lorvic Corp. |
FEI Numbers
This FDA classification entry is associated with 61 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 61 registration numbers. Click on an entry to view related FDA registrations.