The following data is part of a premarket notification filed by Cefla S.c. with the FDA for S200, S300.
| Device ID | K133412 |
| 510k Number | K133412 |
| Device Name: | S200, S300 |
| Classification | Unit, Operative Dental |
| Applicant | CEFLA S.C. 110 E. GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Contact | Berthoin Claude |
| Correspondent | Berthoin Claude CEFLA S.C. 110 E. GRANADA BLVD. SUITE 207 Ormond Beach, FL 32176 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-07 |
| Decision Date | 2015-01-08 |