The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Modification To Kavo Quattrocare.
Device ID | K071288 |
510k Number | K071288 |
Device Name: | MODIFICATION TO KAVO QUATTROCARE |
Classification | Material, Tooth Shade, Resin |
Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVE. Orange, CA 92867 |
Contact | Colleen Boswell |
Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVE. Orange, CA 92867 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-05-08 |
Decision Date | 2007-07-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
EKAV100838050 | K071288 | 000 |
EKAV100545240 | K071288 | 000 |
EKAV100538440 | K071288 | 000 |