The following data is part of a premarket notification filed by Southern Dental Industries, Inc. with the FDA for Riva Light Cure.
Device ID | K050870 |
510k Number | K050870 |
Device Name: | RIVA LIGHT CURE |
Classification | Cement, Dental |
Applicant | SOUTHERN DENTAL INDUSTRIES, INC. 5 BRUNSDON ST 3125 Bayswater Vi 3125, AU |
Contact | Ray Cahill |
Correspondent | Ray Cahill SOUTHERN DENTAL INDUSTRIES, INC. 5 BRUNSDON ST 3125 Bayswater Vi 3125, AU |
Product Code | EMA |
Subsequent Product Code | EBC |
Subsequent Product Code | EBF |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-04-06 |
Decision Date | 2005-06-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
DO3687300061 | K050870 | 000 |
DO3687001081 | K050870 | 000 |
DO3687001071 | K050870 | 000 |
DO3687001041 | K050870 | 000 |
DO3687001031 | K050870 | 000 |
DO3687001021 | K050870 | 000 |
DO3687001011 | K050870 | 000 |
DO3687000161 | K050870 | 000 |
DO3687000141 | K050870 | 000 |
DO3687000121 | K050870 | 000 |
DO3687000101 | K050870 | 000 |
DO3687000081 | K050870 | 000 |
DO3687000071 | K050870 | 000 |
DO3687000051 | K050870 | 000 |
DO3687000041 | K050870 | 000 |
DO3687000031 | K050870 | 000 |
DO3687000021 | K050870 | 000 |
DO3687001121 | K050870 | 000 |
DO3687001141 | K050870 | 000 |
DO3687300041 | K050870 | 000 |
DO3687300031 | K050870 | 000 |
DO3687300021 | K050870 | 000 |
DO3687300011 | K050870 | 000 |
DO3687100021 | K050870 | 000 |
DO3687100011 | K050870 | 000 |
DO3687100001 | K050870 | 000 |
DO3687009001 | K050870 | 000 |
DO3687005121 | K050870 | 000 |
DO3687005071 | K050870 | 000 |
DO3687005051 | K050870 | 000 |
DO3687005041 | K050870 | 000 |
DO3687005031 | K050870 | 000 |
DO3687005021 | K050870 | 000 |
DO3687005011 | K050870 | 000 |
DO3687001161 | K050870 | 000 |
DO3687000011 | K050870 | 000 |