The following data is part of a premarket notification filed by Cdb Corp. with the FDA for Reflections - Ceramic Dental Bracket.
Device ID | K922499 |
510k Number | K922499 |
Device Name: | REFLECTIONS - CERAMIC DENTAL BRACKET |
Classification | Bracket, Metal, Orthodontic |
Applicant | CDB CORP. 3625 HIGHWAY 421 NORTH Wilmington, NC 28401 |
Contact | Sylvia C Joye |
Correspondent | Sylvia C Joye CDB CORP. 3625 HIGHWAY 421 NORTH Wilmington, NC 28401 |
Product Code | EJF |
CFR Regulation Number | 872.5410 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-27 |
Decision Date | 1992-07-30 |