EEF
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Clamp, Rubber Dam
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.6300
- Medical specialty
- Dental
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2012: 37 · 2013: 23 · 2014: 13 · 2015: 10 · 2016: 8 · 2018: 11
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 |
|---|---|---|
| FIXAFLOSS (K071615) | Sybron Dental Specialties, Inc. | 2007-09-21 |
| DISPOSABLE RADIOLUCENT RUBBER DAM CLAMP (K915207) | Bay Technical Products, Inc. | 1992-02-14 |
| BRINKER TISSUE RETRACTORS (K780744) | Hygienic Dental Mfg., Co., The | 1978-05-12 |
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Every clearance here is in the API, with alerts when new ones post.