The following data is part of a premarket notification filed by Classone Orthodontics, Inc. with the FDA for Select Defense Dental Pit And Fissure Sealant.
| Device ID | K093059 |
| 510k Number | K093059 |
| Device Name: | SELECT DEFENSE DENTAL PIT AND FISSURE SEALANT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | CLASSONE ORTHODONTICS, INC. 5064 50TH ST. Lubbock, TX 79414 |
| Contact | Judy Ribordy |
| Correspondent | Judy Ribordy CLASSONE ORTHODONTICS, INC. 5064 50TH ST. Lubbock, TX 79414 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-30 |
| Decision Date | 2010-02-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858290006574 | K093059 | 000 |
| 00858290006567 | K093059 | 000 |
| 00858290006536 | K093059 | 000 |
| 00858290006529 | K093059 | 000 |
| D8281330231 | K093059 | 000 |
| D8281330229 | K093059 | 000 |