NITE-GUIDE
Positioner, Tooth, Preformed
ORTHO-TAIN, INC.
The following data is part of a premarket notification filed by Ortho-tain, Inc. with the FDA for Nite-guide.
Pre-market Notification Details
| Device ID | K931615 |
| 510k Number | K931615 |
| Device Name: | NITE-GUIDE |
| Classification | Positioner, Tooth, Preformed |
| Applicant | ORTHO-TAIN, INC. 85TH FLOOR SEARS TOWER Chicago, IL 60606 |
| Contact | Kay E Rickelman |
| Correspondent | Kay E Rickelman ORTHO-TAIN, INC. 85TH FLOOR SEARS TOWER Chicago, IL 60606 |
| Product Code | KMY |
| CFR Regulation Number | 872.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-01 |
| Decision Date | 1995-04-14 |
Trademark Results [NITE-GUIDE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NITE-GUIDE 74394748 not registered Dead/Abandoned |
BERGERSEN, EARL O. 1993-05-26 |
 NITE-GUIDE 74391021 1819835 Live/Registered |
ORTHO-TAIN, INC. 1993-05-17 |
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