DENTURE-TIGHT
FDA 510(k) clearance K790589 · decided 1979-08-10
Clearance details
- K-number
- K790589
- Device name
- DENTURE-TIGHT
- Applicant
- Den-Mat Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-03-27
- Decision date
- 1979-08-10
- Days to decision
- 136 days
- Clearance type
- Traditional
- Product code
- EBP
- Device class
- 2
- Regulation number
- 872.3560
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PROSOFT (K121318) | Perma Laboratories | 2012-06-06 |
| RELINE-IT MODEL RELINE-IT (K101771) | Majestic Drug Co., Inc. | 2010-09-20 |
Recalls involving this device
No recalls on record reference this clearance.