SmileSeries
Aligner, Sequential
Ordont Orthodontic Laboratories, Inc.
The following data is part of a premarket notification filed by Ordont Orthodontic Laboratories, Inc. with the FDA for Smileseries.
Pre-market Notification Details
| Device ID | K221097 |
| 510k Number | K221097 |
| Device Name: | SmileSeries |
| Classification | Aligner, Sequential |
| Applicant | Ordont Orthodontic Laboratories, Inc. 1755 Smizer Station Road Fenton, MO 63026 |
| Contact | Paul Rudzicka |
| Correspondent | Patsy J Trisler Trisler Consulting, Dba 7949 Beaumont Green East Drive Indianapolis, IN 46250 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-14 |
| Decision Date | 2022-07-14 |
Trademark Results [SmileSeries]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SMILESERIES 87148309 5180676 Live/Registered |
Ordont Orthodontic Laboratories, Inc. 2016-08-23 |
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