Disposable Prophylaxis Angle
by Preventive Technologies, Inc.
510(k) K951016
Disposable Prophylaxis Angle is a medical device (FDA Class I; FDA product code EHK, Cup, Prophylaxis) made by Preventive Technologies, Inc., cleared under FDA 510(k) K951016 on 2 May 1995, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK951016 | Date2 May 1995 | StatusActive |
Official records
- FDA 510(k) database K951016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EHK
- Device class
- Class I
- Regulation
- 21 CFR Part 872.6290
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K951016
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
Similar devices
Other devices filed under FDA product code EHK (Cup, Prophylaxis).
- DENTAL PROPHY CUPS (VARIOUS TYPES) by Mission White Dental, Inc.
- PROPHY CUPS, R&R by Ransom and Randolph
- PROPHYLAXIS CUPS AND POLISHERS by YOUNG DENTAL MANUFACTURING CO 1, LLC.
- DISPOSABLE SCREW TYPE PROPHY BRUSH by Dentsply Intl.
- PRO-KUP by Dental Control Products
- PROPHY ANGLE by Rolence Enterprise Co., Ltd.
- PROPHYLAXIS CUP. by Teledyne Densco