The following data is part of a premarket notification filed by Led Dental Inc with the FDA for Tuxedo Digital Dental Sensor.
| Device ID | K153710 |
| 510k Number | K153710 |
| Device Name: | Tuxedo Digital Dental Sensor |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | LED DENTAL INC NO.235-5589 BYRNE RD. Burnaby, CA V5j 3j1 |
| Contact | Wesley Newsom |
| Correspondent | Daniel Kamm KAMM & ASSOCIATES 8870 RAVELLO CT Naples, FL 34114 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-24 |
| Decision Date | 2016-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00754020100072 | K153710 | 000 |
| 07540201000063 | K153710 | 000 |
| 00860008321336 | K153710 | 000 |
| 00860008321329 | K153710 | 000 |
| 00860008321312 | K153710 | 000 |
| 00860008321305 | K153710 | 000 |
| 00860008321374 | K153710 | 000 |
| 00860008321367 | K153710 | 000 |
| 00860008321350 | K153710 | 000 |
| 07540201000070 | K153710 | 000 |
| 07540201000216 | K153710 | 000 |
| 00754020100065 | K153710 | 000 |
| 00754020100249 | K153710 | 000 |
| 00754020100232 | K153710 | 000 |
| 00754020100225 | K153710 | 000 |
| 00754020100218 | K153710 | 000 |
| 07540201000247 | K153710 | 000 |
| 07540201000230 | K153710 | 000 |
| 07540201000223 | K153710 | 000 |
| 00860008321343 | K153710 | 000 |