Product code EFH
- Device name
- Paper, Articulation
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6140
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K965026 | PFINGST PRESSURE PASTE | Pfingst & Co., Inc. | 1997-02-10 |
| K912632 | OCCLUDE | Pascal Co., Inc. | 1992-01-17 |
| K911259 | HYDENT | Pascal Co., Inc. | 1991-06-06 |
| K864572 | FIXTECTOR | Prodent Intl., Inc. | 1987-02-12 |
| K870032 | REVISED T-SCAN SYSTEM | Sentek, Inc. | 1987-02-02 |
| K832647 | ARTICULATING PAPER | Ardent Intl., Inc. | 1984-02-21 |
| K833132 | MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY | Myo-Tronics Research, Inc. | 1984-02-10 |
| K810498 | CENTRIC (BITE) REGISTRATION PASTE | Wallace A. Erickson & Co. | 1981-03-17 |
| K771011 | ARTICULATING PAPER | Parker Laboratories, Inc. | 1977-06-20 |
| K770492 | CRACK DETECTOR, DEN-MAT | Dey-Mat, Inc. | 1977-03-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10732224001712 | Articulating Paper | CROSSTEX INTERNATIONAL, INC. | 2024-04-12 |
| 10732224001866 | Articulating Film | CROSSTEX INTERNATIONAL, INC. | 2022-09-29 |
| 10732224001842 | Articulating Fim | CROSSTEX INTERNATIONAL, INC. | 2022-09-29 |
| 10732224001729 | Articulating Paper | CROSSTEX INTERNATIONAL, INC. | 2022-09-29 |
| 10732224001743 | Articulating Paper | CROSSTEX INTERNATIONAL, INC. | 2022-09-29 |
| 10732224001750 | Articulating Paper | CROSSTEX INTERNATIONAL, INC. | 2022-09-29 |
| 10732224001781 | Articulating Paper | CROSSTEX INTERNATIONAL, INC. | 2022-09-29 |
| 10732224001835 | Articulating Film | CROSSTEX INTERNATIONAL, INC. | 2022-09-29 |
| 10810000526168 | AccuFilm® | PARKELL, INC. | 2021-10-01 |
| 10810000526175 | AccuFilm® | PARKELL, INC. | 2021-10-01 |
| 10810000526199 | AccuFilm® | PARKELL, INC. | 2021-10-01 |
| 10810000526670 | AccuFilm® | PARKELL, INC. | 2021-10-01 |
| B9702001BOX0 | Large T-Scan Evolution Sensors (Box of 10) | Tekscan, Inc. | 2020-11-03 |
| B9702001BOX200 | Large T-Scan Evolution Sensors (Box of 20) | Tekscan, Inc. | 2020-11-03 |
| B9702002BOX0 | Large T-Scan Novus Sensors (10 per Box) | Tekscan, Inc. | 2020-11-03 |
| B9702002BOX200 | Large T-Scan Novus Sensors (20 per Box) | Tekscan, Inc. | 2020-11-03 |
| 10381780504085 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2020-10-01 |
| 10381780496915 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-10-24 |
| 10381780496922 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-10-24 |
| 10381780496908 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-10-24 |
| 10810000526144 | AccuFilm® | PARKELL, INC. | 2018-10-19 |
| 10810000526137 | AccuFilm® | PARKELL, INC. | 2018-10-19 |
| 10810000526083 | AccuFilm® | PARKELL, INC. | 2018-10-19 |
| 10810000526076 | AccuFilm® | PARKELL, INC. | 2018-10-19 |
| 10381780501350 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-18 |
| 10381780501343 | Integra® Miltex® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-18 |
| 10841396117296 | Flex Tab | KERR CORPORATION | 2016-08-31 |
| 10841396117302 | Flex Tab | KERR CORPORATION | 2016-08-31 |
| 10841396117319 | Flex Tab | KERR CORPORATION | 2016-08-31 |
| 10841396117326 | Flex Tab | KERR CORPORATION | 2016-08-31 |