Product code EMR
- Device name
- File, Periodontic
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.4565
- 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 |
|---|---|---|---|
| K830109 | CIMPAT | North Pacific Dental, Inc. | 1983-03-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D928400435RD0 | PERIO FILE SCHLUGER 9/10 D/E ROUND HANDLE | W.H. Holden, Inc. | 2026-03-18 |
| D928400400HF0 | PERIO FILE SUGARMAN 1S/2S D/E HF HANDLE | W.H. Holden, Inc. | 2026-03-18 |
| D928400400HD0 | PERIO FILE SUGARMAN 1S/2S D/E HD HANDLE | W.H. Holden, Inc. | 2026-03-18 |
| D928400400CH0 | PERIO FILE SUGARMAN 1S/2S D/E CH HANDLE | W.H. Holden, Inc. | 2026-03-18 |
| D9284004002CH0 | PERIO FILE SUGARMAN 2S D/E CH HANDLE SPECIAL DR SIN | W.H. Holden, Inc. | 2026-03-18 |
| D9284004001CH0 | PERIO FILE SUGARMAN 1S D/E CH HANDLE SPECIAL DR SIN | W.H. Holden, Inc. | 2026-03-18 |
| 00840018665774 | Nordent Manufacturing, Inc. | NORDENT MANUFACTURING INC | 2026-02-09 |
| 00840018665767 | Nordent Manufacturing, Inc. | NORDENT MANUFACTURING INC | 2026-02-09 |
| 00841336110854 | Salvin Dental Specialties | SALVIN DENTAL SPECIALTIES, LLC | 2024-12-11 |
| 00813677024756 | PDT, Inc. | PDT, INC. | 2024-05-22 |
| 00842517119055 | Karl Schumacher | Karl Schumacher Dental, LLC | 2024-05-06 |
| 00842517119048 | Karl Schumacher | Karl Schumacher Dental, LLC | 2024-05-06 |
| 00842517118973 | Karl Schumacher | Karl Schumacher Dental, LLC | 2024-05-06 |
| 00842517113688 | Karl Schumacher | Karl Schumacher Dental, LLC | 2024-05-06 |
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| 07899798200234 | Quinelato | Schobell Industrial Ltda | 2023-01-09 |
| 07899798200227 | Quinelato | Schobell Industrial Ltda | 2023-01-09 |
| 07898506852093 | Quinelato | Schobell Industrial Ltda | 2023-01-09 |
| 07898506852086 | Quinelato | Schobell Industrial Ltda | 2023-01-09 |
| 07898506851645 | Quinelato | Schobell Industrial Ltda | 2023-01-09 |
| 07898506811021 | Quinelato | Schobell Industrial Ltda | 2023-01-09 |
| 00887919761112 | Brasseler USA | Peter Brasseler Holdings, LLC | 2022-12-08 |
| 00887919761143 | Brasseler USA | Peter Brasseler Holdings, LLC | 2022-12-08 |