Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Southern Dental Industries, Inc. · Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
112 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062065 | RIVA LUTING PLUS | Southern Dental Industries, Inc. | 2006-11-15 | 118 | 0 |
| K062064 | RIVA BOND LC | Southern Dental Industries, Inc. | 2006-11-09 | 112 | 0 |
| K050871 | RIVA PROTECT | Southern Dental Industries, Inc. | 2005-06-10 | 65 | 0 |
| K050870 | RIVA LIGHT CURE | Southern Dental Industries, Inc. | 2005-06-03 | 58 | 0 |
| K050331 | ADHESIVE 1 | Southern Dental Industries, Inc. | 2005-03-24 | 42 | 0 |
| K042452 | RIVA SILVER | Southern Dental Industries, Inc. | 2004-12-07 | 88 | 0 |
| K040393 | RIVA LUTING | Southern Dental Industries, Inc. | 2004-04-30 | 73 | 0 |
| K032152 | BENCO ADMIX | Southern Dental Industries, Inc. | 2003-08-06 | 70 | 0 |
| K031658 | BENCO SPHERICAL | Southern Dental Industries, Inc. | 2003-07-29 | 62 | 0 |
| K030568 | RADII | Southern Dental Industries, Inc. | 2003-04-24 | 59 | 0 |
| K030516 | RIVA-SELF CURE | Southern Dental Industries, Inc. | 2003-04-17 | 57 | 0 |
| K990650 | CONSEAL F | Southern Dental Industries, Inc. | 1999-05-14 | 74 | 0 |
| K981383 | ALLOYBOND | Southern Dental Industries, Inc. | 1998-06-16 | 61 | 0 |
| K973089 | FREEDOM | Southern Dental Industries, Inc. | 1997-12-08 | 112 | 0 |
| K973091 | WAVE | Southern Dental Industries, Inc. | 1997-12-08 | 112 | 0 |
| K973092 | STAE | Southern Dental Industries, Inc. | 1997-12-08 | 112 | 0 |
| K973086 | PLA-96P | Southern Dental Industries, Inc. | 1997-10-07 | 50 | 0 |
| K973088 | PLS-96P | Southern Dental Industries, Inc. | 1997-10-03 | 46 | 0 |
| K955285 | GALLOY | Southern Dental Industries, Inc. | 1996-01-24 | 68 | 0 |
| K941899 | SDI COMPOSTIES | Southern Dental Industries, Inc. | 1994-07-05 | 77 | 0 |
| K801639 | PERMITE DENTAL AMALGAM ALLOY | Southern Dental Industries, Inc. | 1980-08-27 | 41 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda