MPI DENTURE ADHESIVE FILM SEALS
FDA 510(k) clearance K941365 · decided 1994-04-22
Clearance details
- K-number
- K941365
- Device name
- MPI DENTURE ADHESIVE FILM SEALS
- Applicant
- Medical Polymers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-03-21
- Decision date
- 1994-04-22
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- KOT
- Device class
- 1
- Regulation number
- 872.3490
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Austin, TX, 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 |
|---|---|---|
| SUPER POLI-GRIP DENTURE ADHESIVE CREAM (K945462) | Block Drug Company, Inc. | 1994-12-20 |
| SUPER STRENGTH DENTURE ADHESIVE CREAM (K903568) | Teledyne Getz | 1990-10-24 |
| STEADFAST DENTURE ADHESIVE CREAM (K895818) | Stiefel Research Institute, Inc. | 1990-04-03 |
| PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM (K884357) | Precision Dynamics Corp. | 1988-11-01 |
| SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER (K872225) | Block Drug Company, Inc. | 1987-06-30 |
| RIGIDENT CREAM (K854430) | Armkel, LLC | 1986-03-04 |
| DENTURE ADHESIVE SEALS (K831493) | Johnson & Johnson Professionals, Inc. | 1983-06-30 |
Recalls involving this device
No recalls on record reference this clearance.