EHK
8 FDA 510(k) clearances · Product code
57 daysmedian time to decision
67 days90th percentile
8clearances measured
FDA profile
- Official device name
- Cup, Prophylaxis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 872.6290
- Medical specialty
- Dental
- Flags
- GMP exempt
- 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 |
|---|---|---|
| PROPHY ANGLE (K953628) | Rolence Enterprise Co. , Ltd. | 1995-09-29 |
| DISPOSABLE PROPHYLAXIS ANGLE (K951016) | Preventive Technologies, Inc. | 1995-05-02 |
| DISPOSABLE SCREW TYPE PROPHY BRUSH (K900507) | Dentsply Intl. | 1990-04-10 |
| DENTAL PROPHY CUPS (VARIOUS TYPES) (K864059) | Mission White Dental, Inc. | 1986-11-19 |
| PROPHYLAXIS CUP. (K803155) | Teledyne Densco | 1981-01-08 |
| PROPHYLAXIS CUPS AND POLISHERS (K790723) | Young Dental Manufacturing Co. 1, LLC | 1979-06-15 |
| PROPHY CUPS, R&R (K780198) | Ransom and Randolph | 1978-02-16 |
| PRO-KUP (K770556) | Dental Control Products | 1977-03-24 |
Track EHK automatically
Every clearance here is in the API, with alerts when new ones post.