The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Optibond Solo Plus.
Device ID | K990498 |
510k Number | K990498 |
Device Name: | OPTIBOND SOLO PLUS |
Classification | Agent, Tooth Bonding, Resin |
Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92667 |
Contact | Colleen Boswell |
Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92667 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-17 |
Decision Date | 1999-03-08 |
Summary: | summary |