EMN
5 FDA 510(k) clearances · Product code
68 daysmedian time to decision
316 days90th percentile
5clearances measured
FDA profile
- Official device name
- Scaler, Periodontic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1996: 1 · 1997: 1 · 1998: 3 · 2001: 1 · 2002: 1 · 2004: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PLAQUE SCRAPER-A INTERPROXIMAL (BETWEEN TEETH) PLAQUE REMOVER, MODEL Z01, Z02 (K070127) | Kevin Vu, Dds | 2007-03-29 |
| DENTAL INSTRUMENTS SCALER (K931330) | Minnesota Prophy Power, Inc. | 1994-01-26 |
| 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS (K851721) | Artiberia | 1985-07-02 |
| BEACH SCALERS (K821786) | Pacific Dental Corp. | 1982-07-06 |
| PERIODONTAL INSTRUMENT #21 GOLDMAN-FOX (K781035) | Premier Dental Products Co. | 1978-06-30 |
Track EMN automatically
Every clearance here is in the API, with alerts when new ones post.