EFH
10 FDA 510(k) clearances · Product code
76 daysmedian time to decision
217 days90th percentile
10clearances measured
FDA profile
- Official device name
- Paper, Articulation
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.6140
- Medical specialty
- Dental
- Flags
- GMP exempt
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PFINGST PRESSURE PASTE (K965026) | Pfingst & Co., Inc. | 1997-02-10 |
| 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 |
Track EFH automatically
Every clearance here is in the API, with alerts when new ones post.