Product code EKN
- Device name
- Point, Paper, Endodontic
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.3830
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K843017 | ABSORBENT ENDODONTIC POINT | United Dental Mfg., Inc. | 1985-01-09 |
| K821625 | ENDODONTIC PAPERPOINTS | Roeko | 1982-06-14 |
| K812886 | ENDODONTIC PAPER POINTS | United Dental Mfg., Inc. | 1981-11-16 |
| K800827 | PREMIER ABSORBENT POINTS | Premier Dental Products Co. | 1980-04-29 |
| K781605 | R&R ABSORBENT POINTS | Ransom and Randolph | 1978-10-10 |
| K761203 | ABSORBENT POINTS | Johnson & Johnson Professionals, Inc. | 1976-12-13 |
| K760983 | ENDODONTIC INSTRUMENTS | Adp Intl., Inc. | 1976-11-15 |
Related GUDID Devices#
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|---|---|---|---|
| 08800069204898 | XP-4D | SURE DENT CORPORATION | 2025-01-07 |
| 08800069204881 | XP-4D | SURE DENT CORPORATION | 2025-01-07 |
| 08800069204874 | XP-4D | SURE DENT CORPORATION | 2025-01-07 |
| 08800069204867 | XP-4D | SURE DENT CORPORATION | 2025-01-07 |
| 08800069204850 | XP-4D | SURE DENT CORPORATION | 2025-01-07 |
| 08800069204522 | FQ KUSA | SURE DENT CORPORATION | 2022-12-01 |
| 08800069204515 | FQ KUSA | SURE DENT CORPORATION | 2022-12-01 |
| 08800069204508 | FQ KUSA | SURE DENT CORPORATION | 2022-12-01 |
| 08800069204492 | FQ KUSA | SURE DENT CORPORATION | 2022-12-01 |
| 08800069204485 | FQ KUSA | SURE DENT CORPORATION | 2022-12-01 |
| 08800069204478 | FQ KUSA | SURE DENT CORPORATION | 2022-12-01 |
| 08800069204461 | FQ KUSA | SURE DENT CORPORATION | 2022-12-01 |
| 08800069204454 | FQ KUSA | SURE DENT CORPORATION | 2022-12-01 |
| 08800069204447 | FQ KUSA | SURE DENT CORPORATION | 2022-12-01 |
| 08800069202849 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202696 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202832 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202825 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202818 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202801 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202795 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202788 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202771 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202764 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202757 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202740 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202733 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202726 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202719 | Minikut | SURE DENT CORPORATION | 2022-09-07 |
| 08800069202702 | Minikut | SURE DENT CORPORATION | 2022-09-07 |