The following data is part of a premarket notification filed by Handpiece Headquarters with the FDA for U-type Contra Angle, U-type Sectional Contra Angle.
| Device ID | K141125 |
| 510k Number | K141125 |
| Device Name: | U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE. Placentia, CA 92870 |
| Contact | Tina Steffanie-oak |
| Correspondent | Tina Steffanie-oak HANDPIECE HEADQUARTERS 620 S. PLACENTIA AVE. Placentia, CA 92870 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-01 |
| Decision Date | 2014-10-23 |
| Summary: | summary |