PFINGST PRESSURE PASTE
FDA 510(k) clearance K965026 · decided 1997-02-10
Clearance details
- K-number
- K965026
- Device name
- PFINGST PRESSURE PASTE
- Applicant
- Pfingst & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-17
- Decision date
- 1997-02-10
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- EFH
- Device class
- 1
- Regulation number
- 872.6140
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- South Plainfield,, NJ, 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 |
|---|---|---|
| OCCLUDE (K912632) | Pascal Co., Inc. | 1992-01-17 |
| HYDENT (K911259) | Pascal Co., Inc. | 1991-06-06 |
| FIXTECTOR (K864572) | Prodent Intl., Inc. | 1987-02-12 |
| REVISED T-SCAN SYSTEM (K870032) | Sentek, Inc. | 1987-02-02 |
| ARTICULATING PAPER (K832647) | Ardent Intl., Inc. | 1984-02-21 |
| MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY (K833132) | Myo-Tronics Research, Inc. | 1984-02-10 |
| CENTRIC (BITE) REGISTRATION PASTE (K810498) | Wallace A. Erickson & Co. | 1981-03-17 |
| ARTICULATING PAPER (K771011) | Parker Laboratories, Inc. | 1977-06-20 |
| CRACK DETECTOR, DEN-MAT (K770492) | Dey-Mat, Inc. | 1977-03-21 |
Recalls involving this device
No recalls on record reference this clearance.