EFH — Paper, Articulation Class I
FDA product code EFH covers "Paper, Articulation", a Class I medical device regulated under 21 CFR 872.6140. Submissions are reviewed by the Dental panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EFH
- Device Class
- Class I
- Regulation Number
- 872.6140
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K965026 | pfingst and co | PFINGST PRESSURE PASTE | February 10, 1997 |
| K912632 | pascal co | OCCLUDE | January 17, 1992 |
| K911259 | pascal co | HYDENT | June 6, 1991 |
| K864572 | prodent intl | FIXTECTOR | February 12, 1987 |
| K870032 | sentek | REVISED T-SCAN SYSTEM | February 2, 1987 |
| K832647 | ardent intl | ARTICULATING PAPER | February 21, 1984 |
| K833132 | myo-tronics research | MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY | February 10, 1984 |
| K810498 | wallace a. erickson and | CENTRIC (BITE) REGISTRATION PASTE | March 17, 1981 |
| K771011 | parker laboratories | ARTICULATING PAPER | June 20, 1977 |
| K770492 | dey-mat | CRACK DETECTOR, DEN-MAT | March 21, 1977 |