510(k) K791716
- Device
- PLAQUE-X DENTURE CLEANSER
- Applicant
- NOXELL
- 510(k) number
- K791716
- Product code
- JER
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-10-23
- Date received
- 1979-08-31
- Regulation
- 872.3530
- Classification name
- Cleaner, Denture, Mechanical
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3011774865
- 3008887731
- 3015989868
- 3043648115
- 1719513
- 3008559238
- 3012896103
- 3017498782
- 3001065024
- 2511556
- 3008774899
- 3043654467
- 1036212
- 3013521677
- 3002912391
- 3006186796
- 3020994856
- 3030446844
- 3042244574
- 1058458
- 3009171220
- 2436918
- 9616246
- 2210679
- 2000004234
- 3018994966
- 1483306
- 3003199211
- 1000071265
- 3015217632
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JER #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K883403 | DENTA PLUS | Connoisseurs Products Corp. | 1988-10-25 |
| K881391 | ULTRASONIC DENTURE CLEANER | Tatung Company of America, Inc. | 1988-08-26 |
| K872521 | DENTURE CLEANSERS | Dental Research Laboratories | 1987-08-11 |
| K852906 | DURACLEAN DENTURE CLEANER | Astron Dental Corp. | 1985-07-31 |
| K840805 | ORAL SAFE | Great Lakes Orthodontics, Ltd. | 1984-03-30 |
| K832359 | ORAL SAFE | Great Lakes Orthodontics, Ltd. | 1983-09-26 |
| K832387 | DENTURE CLEANER | Tower Laboratories, Ltd. | 1983-09-12 |
| K800166 | DENTSPLY DENTURE CLEANER | Dentsply Intl. | 1980-03-17 |
| K792530 | PLAQUE-X DENTURE CLEANER | Nexell Corp. | 1979-12-27 |
| K791925 | DEN-MAT 4-MINUTE DENTURE CLEANER | Den-Mat Corp. | 1979-10-26 |
| K781779 | SANI-DENT DENTURE CLEANER | Sandi-Dent | 1978-11-08 |
| K780254 | DENTURE CLEANSER & TOOTHPASTE IN ONE | Richardson Merrel, Inc. | 1978-03-09 |
| K780174 | ORABRITE | Norcliff Thayer, Inc. | 1978-02-23 |
Legacy Summary#
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FDA Review#
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