The following data is part of a premarket notification filed by Kaltenbach & Voigt Gmbh & Co. with the FDA for Intra Lux Head 3 Ldsy.
| Device ID | K092446 |
| 510k Number | K092446 |
| Device Name: | INTRA LUX HEAD 3 LDSY |
| Classification | Handpiece, Belt And/or Gear Driven, Dental |
| Applicant | KALTENBACH & VOIGT GMBH & CO. 1717 WEST COLLINS Orange, CA 92867 |
| Contact | Claudia Ortiz |
| Correspondent | Claudia Ortiz KALTENBACH & VOIGT GMBH & CO. 1717 WEST COLLINS Orange, CA 92867 |
| Product Code | EFA |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-10 |
| Decision Date | 2009-11-03 |
| Summary: | summary |