EGZ
8 FDA 510(k) clearances · Product code
59 daysmedian time to decision
158 days90th percentile
8clearances measured
FDA profile
- Official device name
- Holder, Film, X-Ray
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.1905
- Medical specialty
- Dental
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2002: 2
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 |
|---|---|---|
| SALIBAG (K913168) | Nix Co. , Ltd. | 1991-09-06 |
| ID-TAB (K913160) | Nix Co. , Ltd. | 1991-09-06 |
| DENTAL X-RAY BITE BLOCK (K890355) | Bite-A-Block | 1989-06-12 |
| TROLL-BITE (K853451) | Trollplast, Inc. | 1986-01-21 |
| EZX YELLOW, BLUE OR ORANGE (K852170) | Strong Marketing | 1985-09-05 |
| S.S. WHITE DENTAL X-RAY FILM HOLDER & ALIGNING ARM (K853005) | The S. S. White Co. | 1985-08-13 |
| UNI-BITE DENTAL X-RAY FILM HOLDER (K813378) | Rinn Corp. | 1982-01-29 |
| KWIX-BITE X-RAY FILM HOLDER (K801079) | Henry Schein, Inc. | 1980-05-20 |
Track EGZ automatically
Every clearance here is in the API, with alerts when new ones post.