Cleaner, Denture, Mechanical
A Mechanical Denture Cleaner is a device that uses vibration, rotation, or ultrasonic energy to remove debris, stains, and deposits from removable dental prostheses, supporting prosthetic hygiene and longevity. It is classified as FDA Class 1 (lowest risk), governed solely by general controls. The product code is JER, regulated under 21 CFR 872.3530, within the Dental medical specialty. No special flags apply to this device.
Basic Information
- Product Code
- JER
- Device Class
- FDA class 1
- Regulation Number
- 872.3530
- 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 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K883403 | DENTA PLUS | Oct 25, 1988 | Substantially Equivalent | CONNOISSEURS PRODUCTS CORP. |
| K881391 | ULTRASONIC DENTURE CLEANER | Aug 26, 1988 | Substantially Equivalent | TATUNG COMPANY OF AMERICA, INC. |
| K872521 | DENTURE CLEANSERS | Aug 11, 1987 | Substantially Equivalent | DENTAL RESEARCH LABORATORIES |
| K852906 | DURACLEAN DENTURE CLEANER | Jul 31, 1985 | Substantially Equivalent | ASTRON DENTAL CORP. |
| K840805 | ORAL SAFE | Mar 30, 1984 | Substantially Equivalent | GREAT LAKES ORTHODONTICS, LTD. |
| K832359 | ORAL SAFE | Sep 26, 1983 | Substantially Equivalent | GREAT LAKES ORTHODONTICS, LTD. |
| K832387 | DENTURE CLEANER | Sep 12, 1983 | Substantially Equivalent | TOWER LABORATORIES, LTD. |
| K800166 | DENTSPLY DENTURE CLEANER | Mar 17, 1980 | Substantially Equivalent | DENTSPLY INTL. |
| K792530 | PLAQUE-X DENTURE CLEANER | Dec 27, 1979 | Substantially Equivalent | NEXELL CORP. |
| K791925 | DEN-MAT 4-MINUTE DENTURE CLEANER | Oct 26, 1979 | Substantially Equivalent | DEN-MAT CORP. |
| K791716 | PLAQUE-X DENTURE CLEANSER | Oct 23, 1979 | Substantially Equivalent | NOXELL |
| K781779 | SANI-DENT DENTURE CLEANER | Nov 08, 1978 | Substantially Equivalent | SANDI-DENT |
| K780254 | DENTURE CLEANSER & TOOTHPASTE IN ONE | Mar 09, 1978 | Substantially Equivalent | RICHARDSON MERREL, INC. |
| K780174 | ORABRITE | Feb 23, 1978 | Substantially Equivalent | NORCLIFF THAYER, INC. |
FEI Numbers
This FDA classification entry is associated with 25 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 25 registration numbers. Click on an entry to view related FDA registrations.