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 |