The following data is part of a premarket notification filed by Lancer Orthodontics, Inc. with the FDA for Storm Mini Screw.
| Device ID | K122069 |
| 510k Number | K122069 |
| Device Name: | STORM MINI SCREW |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | LANCER ORTHODONTICS, INC. 2330 Cousteau Court Vista, CA 92081 |
| Contact | Larry Walker |
| Correspondent | Larry Walker LANCER ORTHODONTICS, INC. 2330 Cousteau Court Vista, CA 92081 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-16 |
| Decision Date | 2013-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817573024551 | K122069 | 000 |
| 00817573022885 | K122069 | 000 |
| 00817573022878 | K122069 | 000 |
| 00817573022847 | K122069 | 000 |
| 00817573022830 | K122069 | 000 |
| 00817573022823 | K122069 | 000 |
| 00817573022816 | K122069 | 000 |