The following data is part of a premarket notification filed by W & H Dentalwerk Buermoos Gmbh with the FDA for Cordless Endo Handpieces Eb-300, Entran And Eb-300 S, S5 Endo Motor.
| Device ID | K090931 |
| 510k Number | K090931 |
| Device Name: | CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | W & H DENTALWERK BUERMOOS GMBH 53 IGNAZ-GLASER-STRASSE Buermoos, Salzburg, AT A-5111 |
| Contact | Johann Georg Scharl |
| Correspondent | Johann Georg Scharl W & H DENTALWERK BUERMOOS GMBH 53 IGNAZ-GLASER-STRASSE Buermoos, Salzburg, AT A-5111 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-02 |
| Decision Date | 2009-12-15 |
| Summary: | summary |