Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Confi-Dental Products Co. · Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
259 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K030807 | CARIES INDICATOR | Confi-Dental Products Co. | 2003-06-09 | 88 | 0 |
| K030743 | ETCHANT 40% | Confi-Dental Products Co. | 2003-05-09 | 60 | 0 |
| K955328 | CONFI-BOND | Confi-Dental Products Co. | 1996-03-28 | 129 | 0 |
| K955329 | RESILIENCE M5 PROTECTION PLUS | Confi-Dental Products Co. | 1996-03-28 | 129 | 0 |
| K954988 | CRYSTALLESSENCE | Confi-Dental Products Co. | 1996-03-08 | 129 | 0 |
| K952930 | DENTRAY II PLUS TRAY ADHESIVE | Confi-Dental Products Co. | 1995-09-08 | 81 | 0 |
| K946307 | CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE | Confi-Dental Products Co. | 1995-01-26 | 29 | 0 |
| K940546 | GRANITEC IONOMER RESIN CEMENT | Confi-Dental Products Co. | 1994-04-29 | 81 | 0 |
| K936070 | TREND SET 2 PLUS | Confi-Dental Products Co. | 1994-02-04 | 46 | 0 |
| K935714 | CRYSTALLINE L3 MULTI-USE HYBRID COMPOSITE | Confi-Dental Products Co. | 1994-01-21 | 52 | 0 |
| K933199 | CRYSTALLINE 'FLUORITE' CORE BUILD-UP MATERIAL | Confi-Dental Products Co. | 1994-01-06 | 266 | 0 |
| K932002 | BARITONE C2, MODIFICATION | Confi-Dental Products Co. | 1993-07-22 | 98 | 0 |
| K931857 | SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT | Confi-Dental Products Co. | 1993-07-22 | 100 | 0 |
| K925359 | RESILIENCE ORTHODONTIC BRACKET ADHES W/BOND RESINS | Confi-Dental Products Co. | 1993-07-08 | 259 | 0 |
| K920533 | DENTIN BONDING AGENT | Confi-Dental Products Co. | 1993-05-19 | 469 | 0 |
| K920843 | TOOTH CONDITIONER | Confi-Dental Products Co. | 1993-04-08 | 408 | 0 |
| K914317 | ORTHODONTIC BRACKET ADHESIVE RESIN MATERIAL | Confi-Dental Products Co. | 1992-03-26 | 182 | 0 |
| K920534 | PORCELAIN PRIMER | Confi-Dental Products Co. | 1992-03-26 | 50 | 0 |
| K914318 | GLASS IONOMER CEMENT | Confi-Dental Products Co. | 1992-03-20 | 176 | 0 |
| K914325 | ROOT CANAL FILLING CEMENT | Confi-Dental Products Co. | 1992-03-09 | 165 | 0 |
| K914324 | CAVITY VARNISH PRODUCT | Confi-Dental Products Co. | 1991-12-27 | 92 | 0 |
| K914319 | PIT AND FISSURE SEALANT PRODUCTS | Confi-Dental Products Co. | 1991-10-23 | 27 | 0 |
| K914322 | BARITONE C2 & BARITONE L3 | Confi-Dental Products Co. | 1991-10-23 | 27 | 0 |
| K902817 | SURGI PAK NE AND COCOMENT EUGENAL FREE PASTE SYST | Confi-Dental Products Co. | 1990-08-28 | 62 | 0 |
| K902635 | MODIFIED GRANITEC P2 & G2 DENTAL CEMENTS | Confi-Dental Products Co. | 1990-07-10 | 28 | 0 |
| K896950 | CORE BUILD UP COMPOSITE | Confi-Dental Products Co. | 1990-03-13 | 90 | 0 |
| K896649 | GRANITEC Z2, ZINC PHOSPHATE CEMENT | Confi-Dental Products Co. | 1990-02-22 | 90 | 0 |
| K894953 | GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS | Confi-Dental Products Co. | 1990-02-06 | 186 | 0 |
| K894890 | CRYSTALLINE C2 AND CRYSTALLINE L3 | Confi-Dental Products Co. | 1989-10-27 | 87 | 0 |
| K891463 | ADHERENCE M5 MULTI-CURE COMPOSITE CEMENT SYSTEM | Confi-Dental Products Co. | 1989-05-19 | 65 | 0 |
| K891464 | RESILIENCE C2, RESILIENCE L3 & RESILIENCE P4 | Confi-Dental Products Co. | 1989-05-18 | 64 | 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