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#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| G879102184H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879102177H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879102RM340 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G8791024050 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879102213H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879102212H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879102211H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879102197H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879102196H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879102191H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879102187H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879102186H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G879102185H0 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| G8791021850 | DENSOL | DENSOL INTERNATIONAL (PRIVATE) LIMITED | 2026-08-18 |
| 04963931271306 | NA | YDM CORPORATION | 2026-07-09 |
| 04963931271221 | NA | YDM CORPORATION | 2026-07-09 |
| 04963931271290 | NA | YDM CORPORATION | 2026-07-09 |
| 04963931271283 | NA | YDM CORPORATION | 2026-07-09 |
| 04963931271276 | NA | YDM CORPORATION | 2026-07-09 |
| 04963931271269 | NA | YDM CORPORATION | 2026-07-09 |
| 04963931271252 | NA | YDM CORPORATION | 2026-07-09 |
| 04963931271245 | NA | YDM CORPORATION | 2026-07-09 |
| 04963931271238 | NA | YDM CORPORATION | 2026-07-09 |
| 04963931271214 | NA | YDM CORPORATION | 2026-07-09 |
| ESAM12718001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12718101 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12720101 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12721001 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12721101 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM12725101 | STOMA® | Storz am Mark GmbH | 2020-08-27 |