The following data is part of a premarket notification filed by Kerr Dental Materials Center with the FDA for Ez Connect.
Device ID | K000346 |
510k Number | K000346 |
Device Name: | EZ CONNECT |
Classification | Crown And Bridge, Temporary, Resin |
Applicant | KERR DENTAL MATERIALS CENTER 1717 WEST COLLINS AVE. Orange, CA 92867 |
Contact | Colleen Boswell |
Correspondent | Colleen Boswell KERR DENTAL MATERIALS CENTER 1717 WEST COLLINS AVE. Orange, CA 92867 |
Product Code | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-02-03 |
Decision Date | 2000-04-14 |