The following data is part of a premarket notification filed by By Dental Srl with the FDA for Hi Tech Implant, Ht Physio Implant.
| Device ID | K091913 |
| 510k Number | K091913 |
| Device Name: | HI TECH IMPLANT, HT PHYSIO IMPLANT |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | BY DENTAL SRL VIA VECCHIA PROV. LE LUCCHESE 49/FG Serravalle Poli; Pistoia, IT 51030 |
| Contact | Daniele Poli |
| Correspondent | Daniele Poli BY DENTAL SRL VIA VECCHIA PROV. LE LUCCHESE 49/FG Serravalle Poli; Pistoia, IT 51030 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-30 |
| Decision Date | 2009-10-30 |
| Summary: | summary |