The following data is part of a premarket notification filed by Great Lakes Orthodontics, Ltd. with the FDA for Biocryl X.
| Device ID | K083479 |
| 510k Number | K083479 |
| Device Name: | BIOCRYL X |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | GREAT LAKES ORTHODONTICS, LTD. 200 COOPER AVE.DR. Tonawanda, NY 14150 |
| Contact | Mark Lauren |
| Correspondent | Mark Lauren GREAT LAKES ORTHODONTICS, LTD. 200 COOPER AVE.DR. Tonawanda, NY 14150 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-24 |
| Decision Date | 2009-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D7750480020 | K083479 | 000 |
| D7750480010 | K083479 | 000 |