The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Benda Wedge.
| Device ID | K140144 |
| 510k Number | K140144 |
| Device Name: | BENDA WEDGE |
| Classification | Handle, Instrument, Dental |
| Applicant | CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
| Contact | Greg Moreau |
| Correspondent | Greg Moreau CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
| Product Code | EJB |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-22 |
| Decision Date | 2014-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810038092997 | K140144 | 000 |
| 00810038092980 | K140144 | 000 |
| 00810038092973 | K140144 | 000 |
| 00810038092966 | K140144 | 000 |
| 00810038095707 | K140144 | 000 |
| 00810038095691 | K140144 | 000 |
| 00810038095684 | K140144 | 000 |