Redline
Aligner, Sequential
Johns Dental Laboratories
The following data is part of a premarket notification filed by Johns Dental Laboratories with the FDA for Redline.
Pre-market Notification Details
| Device ID | K213297 |
| 510k Number | K213297 |
| Device Name: | Redline |
| Classification | Aligner, Sequential |
| Applicant | Johns Dental Laboratories 423 S. 13th ST Terre Haute, IN 47807 |
| Contact | Marni Buis |
| Correspondent | Na Zhang Evo820, LLC 1 Bay Street Rancho Mission Viejo, CA 92694 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-01 |
| Decision Date | 2022-02-09 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810002220135 | K213297 | 000 |
Trademark Results [Redline]
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