SMILERS
Aligner, Sequential
Biotech Dental Smilers, SAS
The following data is part of a premarket notification filed by Biotech Dental Smilers, Sas with the FDA for Smilers.
Pre-market Notification Details
| Device ID | K212961 |
| 510k Number | K212961 |
| Device Name: | SMILERS |
| Classification | Aligner, Sequential |
| Applicant | Biotech Dental Smilers, SAS 305, Allée De Craponne Salon De Provence, FR 13300 |
| Contact | Delphine Mercier |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-09-16 |
| Decision Date | 2021-09-20 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03770020010071 | K212961 | 000 |
| 03770020010057 | K212961 | 000 |
| 03770020010040 | K212961 | 000 |
| 03770020010026 | K212961 | 000 |
| 03770020010002 | K212961 | 000 |
Trademark Results [SMILERS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMILERS 79236745 not registered Live/Pending |
BIOTECH DENTAL SMILERS 2018-05-07 |
 SMILERS 79234362 not registered Live/Pending |
BIOTECH DENTAL SMILERS 2018-03-26 |
 SMILERS 74127376 not registered Dead/Abandoned |
SMILERS RED HOTS, INC. 1991-01-02 |
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