The following data is part of a premarket notification filed by Cefla S.c. with the FDA for Stern's S250 Nordam.
| Device ID | K092917 |
| 510k Number | K092917 |
| Device Name: | STERN'S S250 NORDAM |
| 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-22 |
| Decision Date | 2010-06-24 |