Product code EMK
- Device name
- Curette, Surgical, Dental
- 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 |
|---|---|---|---|
| K851718 | 930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES | Artiberia | 1985-07-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B382SD9143681000 | Surgical Direct | Surgical Direct, Inc. | 2026-07-13 |
| 00850083275532 | Intrace USA | PILOTIS TECH LLC | 2026-07-03 |
| 00841336106413 | Salvin Dental Specialties | SALVIN DENTAL SPECIALTIES, LLC | 2026-06-08 |
| G149TBSB7950 | TBS BASICS | ACME ENTERPRISE. | 2026-05-21 |
| G149TBSB7940 | TBS BASICS | ACME ENTERPRISE. | 2026-05-21 |
| G149TBSB7930 | TBS BASICS | ACME ENTERPRISE. | 2026-05-21 |
| G149TBSB7920 | TBS BASICS | ACME ENTERPRISE. | 2026-05-21 |
| G149TBSB7910 | TBS BASICS | ACME ENTERPRISE. | 2026-05-21 |
| G149TBSB7900 | TBS BASICS | ACME ENTERPRISE. | 2026-05-21 |
| G149NPSCL0 | NPS | ACME ENTERPRISE. | 2026-05-01 |
| G149NP380620 | NPS | ACME ENTERPRISE. | 2026-05-01 |
| B382SD914631610 | Surgical Direct | Surgical Direct, Inc. | 2024-07-08 |
| B382SD914631630 | Surgical Direct | Surgical Direct, Inc. | 2024-07-08 |
| B382SD9146531510 | Surgical Direct | Surgical Direct, Inc. | 2024-07-08 |
| B382SD914631540 | Surgical Direct | Surgical Direct, Inc. | 2024-07-02 |
| B382SD914631550 | Surgical Direct | Surgical Direct, Inc. | 2024-07-02 |
| 08800075605221 | OSUNG MND | OSUNG MND Co., Ltd. | 2024-02-22 |
| 08800075605481 | OSUNG MND | OSUNG MND Co., Ltd. | 2024-02-22 |
| 07898506854141 | Quinelato | Schobell Industrial Ltda | 2022-12-08 |
| 07898506854134 | Quinelato | Schobell Industrial Ltda | 2022-12-08 |
| 08800000945927 | Sinus Curette Long type | Osstem Implant Co., Ltd. | 2022-12-08 |
| 08800000945934 | Sinus Curette Short type | Osstem Implant Co., Ltd. | 2022-12-08 |
| 08800000981321 | Gracey Curette | Osstem Implant Co., Ltd. | 2022-12-08 |
| 08800000981338 | Gracey Curette | Osstem Implant Co., Ltd. | 2022-12-08 |
| 08800000981345 | Gracey Curette | Osstem Implant Co., Ltd. | 2022-12-08 |
| 08800000981369 | Metal Curette | Osstem Implant Co., Ltd. | 2022-12-08 |
| B382SD9155971000 | Surgical Direct | Surgical Direct, Inc. | 2022-12-01 |
| ESAM14606031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM14606021 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM14605001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |