The following data is part of a premarket notification filed by Southern Dental Industries, Inc. with the FDA for Riva Bond Lc.
Device ID | K062064 |
510k Number | K062064 |
Device Name: | RIVA BOND LC |
Classification | Cement, Dental |
Applicant | SOUTHERN DENTAL INDUSTRIES, INC. 729 N. ROUTE 83, SUITE 315 Bensenville, IL 60106 |
Contact | Ray Cahill |
Correspondent | Ray Cahill SOUTHERN DENTAL INDUSTRIES, INC. 729 N. ROUTE 83, SUITE 315 Bensenville, IL 60106 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-07-20 |
Decision Date | 2006-11-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
DO3688006121 | K062064 | 000 |
DO3688006111 | K062064 | 000 |
DO3688006101 | K062064 | 000 |