DZN
16 FDA 510(k) clearances · Product code
44 daysmedian time to decision
304 days90th percentile
16clearances measured
FDA profile
- Official device name
- Instruments, Dental Hand
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.4565
- Medical specialty
- Dental
- Adverse events (MAUDE)
- 2021: 21 · 2022: 26 · 2023: 38 · 2024: 69 · 2025: 31 · 2026: 151
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 |
|---|---|---|
| COMPOTHIXO (K111465) | Kerrhawe SA | 2012-07-25 |
| DENTAL MATRIX BAND (K071858) | Fly Cast Technologies, Inc. | 2007-08-31 |
| CONTACT MOLAR BANDS AND CONTOUR STRIPS (K901919) | Ivoclar North America, Inc. | 1990-06-22 |
| CENTRIX PCR MOLAR MATRIX FORMS (BANDS) (K861581) | Centrix, Inc. | 1986-05-12 |
| TIGER BAND (K844324) | World Wide Outdoor Marketing | 1984-12-03 |
| INTERDENTAL WEDGES (K840984) | Healthco, Inc. | 1984-04-13 |
| DENTAL MATRIX BAND (K822094) | Dentsply Intl. | 1982-08-16 |
| COLORED WEDGE USED TO SEPARATE TEETH (K821444) | Moyco Industries, Inc. | 1982-06-14 |
| PALODENT MATRICES & BITINE RINGS (K801142) | Alvin Meyer, D.D.S. | 1980-08-07 |
| COREFORM MOLDS (K801530) | Sybron Corp. | 1980-07-28 |
| HEMO-WEDGE (K790555) | Parker Laboratories, Inc. | 1980-01-17 |
| RUWA MATRIX STRIPS (K790599) | Howmedica Corp. | 1979-05-21 |
| HOWMEDICA STRIP CROWN (K790600) | Howmedica Corp. | 1979-05-21 |
| ACCOR MATRIX (K790633) | Accor, Inc. | 1979-05-17 |
| WEDGES, RETAINING, MATRIX (K772314) | Den-Mat Corp. | 1978-01-03 |
| MATRIX STRIP, DEAD-SOFT (K772316) | Den-Mat Corp. | 1978-01-03 |
Track DZN automatically
Every clearance here is in the API, with alerts when new ones post.