The following data is part of a premarket notification filed by Micro-mega Societe Anonyme with the FDA for Ax's Endo 04, 06, 08, 2.5, 40 , Models 50100206, 50100217, 50100218, 50100230, 50100232.
| Device ID | K042171 |
| 510k Number | K042171 |
| Device Name: | AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232 |
| Classification | Handpiece, Contra- And Right-angle Attachment, Dental |
| Applicant | MICRO-MEGA SOCIETE ANONYME 5-12 RUE DU TUNNEL Cedex Besancon, FR 25006 |
| Contact | Philippe Garcia |
| Correspondent | Philippe Garcia MICRO-MEGA SOCIETE ANONYME 5-12 RUE DU TUNNEL Cedex Besancon, FR 25006 |
| Product Code | EGS |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-11 |
| Decision Date | 2004-11-10 |