SomnoDent Avant
Device, Anti-snoring
SomnoMed Inc.
The following data is part of a premarket notification filed by Somnomed Inc. with the FDA for Somnodent Avant.
Pre-market Notification Details
| Device ID | K183443 |
| 510k Number | K183443 |
| Device Name: | SomnoDent Avant |
| Classification | Device, Anti-snoring |
| Applicant | SomnoMed Inc. 6513 Windcrest Drive Plano, TX 75024 |
| Contact | Dorene Markwiese |
| Correspondent | Dorene Markwiese SomnoMed Inc. 6513 Windcrest Drive Plano, TX 75024 |
| Product Code | LRK |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-12 |
| Decision Date | 2019-05-08 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851826007342 | K183443 | 000 |
| 00851826007335 | K183443 | 000 |
| 00851826007328 | K183443 | 000 |
| 00851826007311 | K183443 | 000 |
| 00851826007304 | K183443 | 000 |
| 00851826007298 | K183443 | 000 |
| 00851826007281 | K183443 | 000 |
Trademark Results [SomnoDent Avant]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOMNODENT AVANT 79251124 not registered Live/Pending |
SomnoMed Limited 2018-12-24 |
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