PROPHY ANGLE
FDA 510(k) clearance K953628 · decided 1995-09-29
Clearance details
- K-number
- K953628
- Device name
- PROPHY ANGLE
- Applicant
- Rolence Enterprise Co. , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-31
- Decision date
- 1995-09-29
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- EHK
- Device class
- 1
- Regulation number
- 872.6290
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Chungli, Taiwan, TW
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
Recalls involving this device
No recalls on record reference this clearance.