Paper, Articulation
FDA product code EFH · Class I (low risk) · 21 CFR 872.6140 · Dental
10510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K965026 | Pfingst Pressure PasteEFH · Traditional | Pfingst & Co., Inc. | 02/10/1997SE |
| K912632 | OccludeEFH · Traditional | Pascal Co., Inc. | 01/17/1992SE |
| K911259 | HydentEFH · Traditional | Pascal Co., Inc. | 06/06/1991SE |
| K864572 | FixtectorEFH · Traditional | Prodent Intl., Inc. | 02/12/1987SE |
| K870032 | Revised T-Scan SystemEFH · Traditional | Sentek, Inc. | 02/02/1987SE |
| K832647 | Articulating PaperEFH · Traditional | Ardent Intl., Inc. | 02/21/1984SE |
| K833132 | Mucosal Adjustment Paste Liquid SprayEFH · Traditional | Myo-Tronics Research, Inc. | 02/10/1984SE |
| K810498 | Centric (Bite) Registration PasteEFH · Traditional | Wallace A. Erickson & Co. | 03/17/1981SE |
| K771011 | Articulating PaperEFH · Traditional | Parker Laboratories, Inc. | 06/20/1977SE |
| K770492 | Crack Detector, Den-MatEFH · Traditional | Dey-Mat, Inc. | 03/21/1977SE |