The following data is part of a premarket notification filed by Rolence Ent. Inc. with the FDA for Rolence Dental High Speed Handpiece, Rhp.
| Device ID | K093084 |
| 510k Number | K093084 |
| Device Name: | ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP |
| Classification | Handpiece, Air-powered, Dental |
| Applicant | ROLENCE ENT. INC. NO.58,FU CHIUN STREET Hsin Chu City, TW 30067 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min ROLENCE ENT. INC. NO.58,FU CHIUN STREET Hsin Chu City, TW 30067 |
| Product Code | EFB |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-01 |
| Decision Date | 2009-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810113690995 | K093084 | 000 |
| 00810113690988 | K093084 | 000 |
| D77813513320 | K093084 | 000 |
| D77813513160 | K093084 | 000 |