The following data is part of a premarket notification filed by Handpiece Headquarters Inc. - Hpr Inc. with the FDA for Spray & Clean Handpiece Cleaner& Lubricant Maxima Handpiece Cleaner & Lubricant Ezcare Handpiece Cleaner & Lubricant.
| Device ID | K113674 |
| 510k Number | K113674 |
| Device Name: | SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | HANDPIECE HEADQUARTERS INC. - HPR INC. 620 S. PLACENTIA AVE Placentia, CA 92870 |
| Contact | Tina Steffanie-oak |
| Correspondent | Tina Steffanie-oak HANDPIECE HEADQUARTERS INC. - HPR INC. 620 S. PLACENTIA AVE Placentia, CA 92870 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-14 |
| Decision Date | 2012-04-05 |
| Summary: | summary |