The following data is part of a premarket notification filed by Cefla S.c. with the FDA for Cefla Dental Micromotors: I-mmr, I-mmr L, I-mms, I-xr3, I-xr3 L, I-xs4, Handy Power, Handy Power Led, Implantor Led.
| Device ID | K213022 |
| 510k Number | K213022 |
| Device Name: | CEFLA Dental Micromotors: I-MMr, I-MMr L, I-MMs, I-XR3, I-XR3 L, I-XS4, Handy POWER, Handy POWER LED, Implantor LED |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | CEFLA S.C. Via Selice Provinciale 23/A Imola, IT 40026 |
| Contact | Lorenzo Bortolotti |
| Correspondent | Lorenzo Bortolotti CEFLA S.C. Via Selice Provinciale 23/A Imola, IT 40026 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-20 |
| Decision Date | 2022-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08033837935032 | K213022 | 000 |
| 08033837935025 | K213022 | 000 |
| 08033837932789 | K213022 | 000 |
| 08033837930747 | K213022 | 000 |
| 08033837930730 | K213022 | 000 |
| 08033837930723 | K213022 | 000 |
| 08033837930402 | K213022 | 000 |
| 08033837930389 | K213022 | 000 |
| 08033837932796 | K213022 | 000 |