DZS
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Capsule, Dental, Amalgam
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.3110
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 1998: 3 · 1999: 1 · 2000: 1 · 2006: 53 · 2007: 8 · 2014: 7
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 |
|---|---|---|
| PRECAPSULED DENTAL AMALGAM (K822610) | Syntex Dental Products, Inc. | 1982-09-14 |
| DISPERSALLOY-DISPERSED PHASE ALLOY SELF- (K802967) | Johnson & Johnson Professionals, Inc. | 1980-12-30 |
| MERCURY DISP. CAPSULE (K781243) | Lee Pharmaceuticals | 1978-09-20 |
| LEE-ALLOY DISPOSABLE CAPSULES (K780966) | Lee Pharmaceuticals | 1978-08-21 |
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Every clearance here is in the API, with alerts when new ones post.