The following data is part of a premarket notification filed by Sybron Corp. with the FDA for Command Bonding Resin/glaze/opaquer.
Device ID | K822869 |
510k Number | K822869 |
Device Name: | COMMAND BONDING RESIN/GLAZE/OPAQUER |
Classification | Coating, Filling Material, Resin |
Applicant | SYBRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EBD |
CFR Regulation Number | 872.3310 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-27 |
Decision Date | 1982-10-13 |