The following data is part of a premarket notification filed by Kaltenbach & Voigt Gmbh with the FDA for Electrotorque Tlc.
| Device ID | K103027 |
| 510k Number | K103027 |
| Device Name: | ELECTROTORQUE TLC |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | KALTENBACH & VOIGT GMBH 1717 WEST COLLINS Orange, CA 92687 |
| Contact | Claudia Ortiz |
| Correspondent | Claudia Ortiz KALTENBACH & VOIGT GMBH 1717 WEST COLLINS Orange, CA 92687 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-13 |
| Decision Date | 2011-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EKAV100701500 | K103027 | 000 |
| EKAV100358400 | K103027 | 000 |
| EKAV100334900 | K103027 | 000 |
| EKAV100250150 | K103027 | 000 |
| EKAV100187480 | K103027 | 000 |
| EKAV101509600 | K103027 | 000 |