Product code EMN
- Device name
- Scaler, 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 |
|---|---|---|---|
| K070127 | PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 | Kevin Vu, Dds | 2007-03-29 |
| K931330 | DENTAL INSTRUMENTS SCALER | Minnesota Prophy Power, Inc. | 1994-01-26 |
| K851721 | 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS | Artiberia | 1985-07-02 |
| K821786 | BEACH SCALERS | Pacific Dental Corp. | 1982-07-06 |
| K781035 | PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX | Premier Dental Products Co. | 1978-06-30 |
Related GUDID Devices#
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|---|---|---|---|
| D94316120 | Power Dental USA | Power Dental U.S.A. Inc. | 2023-03-07 |
| D94316110 | Power Dental USA | Power Dental U.S.A. Inc. | 2023-03-07 |
| D9431612R0 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-07-13 |
| D9431618R0 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-07-13 |
| D9431617R0 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-07-13 |
| D9431616R0 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-07-13 |
| D9431615T0 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-07-13 |
| D9431615R0 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-07-13 |
| D9431614T0 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-07-13 |
| D9431614R0 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-07-13 |
| D9431613R0 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-07-13 |
| D9431611R0 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-07-13 |
| D9431610R0 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-07-13 |
| D9431225M0 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-07-13 |
| D9431226T0 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-07-13 |
| D9431610T0 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-07-13 |
| D94312250 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-06-20 |
| D94316130 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-06-20 |
| D94315240 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-06-20 |
| D94316140 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-06-20 |
| D94315230 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-06-20 |
| D94315220 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-06-20 |
| D94316150 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-06-20 |
| D94312400 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-06-20 |
| D94312390 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-06-20 |
| D94316160 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-06-20 |
| D94316100 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-06-20 |
| D94316170 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-06-20 |
| D94312260 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-06-20 |
| D94316180 | Power Dental USA | Power Dental U.S.A. Inc. | 2021-06-20 |