EIY
5 FDA 510(k) clearances · Product code
48 daysmedian time to decision
68 days90th percentile
5clearances measured
FDA profile
- Official device name
- Instrument, Filling, Plastic, Dental
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 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 |
|---|---|---|
| COMPOSITE RESTORATIVE CARRIER (K871909) | Dentsply Intl. | 1987-05-27 |
| 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN (K851726) | Artiberia | 1985-07-02 |
| NOVEL DISPENSER/PACKAGE (K833955) | Dentsply Intl. | 1984-01-03 |
| MICROFIL CONTOURING INSTRUMENTS (K830776) | Almore Intl., Inc. | 1983-04-28 |
| DENTAL INSTRUMENTS - PLASTIC INSTRUMENTS (K823323) | Miltex, Inc. | 1982-11-24 |
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Every clearance here is in the API, with alerts when new ones post.