Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sybron Dental Specialties, Inc. · Predicate Candidate Screening
106 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
93 days90th percentile
106clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093341 | CENTURY MODEL 105C | Sybron Dental Specialties, Inc. | 2010-04-05 | 164 | 0 |
| K091091 | SONICFILL 2010 | Sybron Dental Specialties, Inc. | 2009-10-14 | 181 | 0 |
| K080089 | SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS | Sybron Dental Specialties, Inc. | 2008-09-04 | 234 | 0 |
| K073478 | SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES | Sybron Dental Specialties, Inc. | 2008-09-03 | 267 | 0 |
| K071615 | FIXAFLOSS | Sybron Dental Specialties, Inc. | 2007-09-21 | 100 | 0 |
| K071288 | MODIFICATION TO KAVO QUATTROCARE | Sybron Dental Specialties, Inc. | 2007-07-19 | 72 | 0 |
| K070327 | REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND | Sybron Dental Specialties, Inc. | 2007-05-25 | 109 | 0 |
| K060469 | OPTIBOND ALL-IN-ONE | Sybron Dental Specialties, Inc. | 2006-03-28 | 33 | 0 |
| K053565 | TEMPBOND CLEAR WITH TRICLOSAN | Sybron Dental Specialties, Inc. | 2006-02-03 | 43 | 0 |
| K051933 | EXPASYL POWER APPLICATOR | Sybron Dental Specialties, Inc. | 2006-01-03 | 174 | 0 |
| K050604 | KERR VPS IMPRESSION MATERIAL | Sybron Dental Specialties, Inc. | 2005-04-15 | 37 | 1 |
| K042422 | D3 CHROMA | Sybron Dental Specialties, Inc. | 2004-11-15 | 69 | 0 |
| K041474 | MAXCEM | Sybron Dental Specialties, Inc. | 2004-07-21 | 49 | 0 |
| K032921 | PREMISE | Sybron Dental Specialties, Inc. | 2003-11-13 | 52 | 0 |
| K032408 | DAMON FT | Sybron Dental Specialties, Inc. | 2003-10-15 | 72 | 0 |
| K032407 | OPTIBAND LC | Sybron Dental Specialties, Inc. | 2003-10-06 | 63 | 0 |
| K032042 | ENVISION | Sybron Dental Specialties, Inc. | 2003-09-29 | 90 | 0 |
| K031476 | FILL-IN | Sybron Dental Specialties, Inc. | 2003-07-02 | 54 | 0 |
| K024198 | SMEARCLEAR | Sybron Dental Specialties, Inc. | 2003-03-05 | 75 | 0 |
| K021797 | L.E.DEMETRON | Sybron Dental Specialties, Inc. | 2002-06-27 | 27 | 0 |
| K020502 | SOLO ORTHO 3 | Sybron Dental Specialties, Inc. | 2002-05-01 | 76 | 0 |
| K020267 | OPTILUX CURING LIGHTS | Sybron Dental Specialties, Inc. | 2002-03-29 | 63 | 0 |
| K013895 | TEMPFIL | Sybron Dental Specialties, Inc. | 2002-02-04 | 73 | 0 |
| K013510 | POINT 4 MODIFIED | Sybron Dental Specialties, Inc. | 2002-01-18 | 88 | 0 |
| K013647 | REVOLUTION FORMULA 2 | Sybron Dental Specialties, Inc. | 2002-01-16 | 72 | 1 |
| K013609 | NEXUS 2 CLEAR | Sybron Dental Specialties, Inc. | 2002-01-16 | 77 | 0 |
| K013529 | POINT 4 TRANSLUCENT MODIFIED | Sybron Dental Specialties, Inc. | 2002-01-09 | 78 | 0 |
| K012717 | LIFE 2 | Sybron Dental Specialties, Inc. | 2001-10-25 | 71 | 0 |
| K013009 | BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 | Sybron Dental Specialties, Inc. | 2001-10-03 | 27 | 0 |
| K013008 | NEXUS 2 MODIFIED | Sybron Dental Specialties, Inc. | 2001-10-02 | 26 | 0 |
| K013007 | BELLEGLASS HP ENAMEL 2 | Sybron Dental Specialties, Inc. | 2001-10-01 | 25 | 0 |
| K012082 | OPTIBOND SOLO PLUS ACTIVATOR | Sybron Dental Specialties, Inc. | 2001-09-20 | 79 | 0 |
| K012405 | EXTRUDE MODIFIED | Sybron Dental Specialties, Inc. | 2001-09-04 | 36 | 0 |
| K012322 | OPTIBOND 2 | Sybron Dental Specialties, Inc. | 2001-08-30 | 38 | 0 |
| K012321 | POINT 4 FLOWABLE | Sybron Dental Specialties, Inc. | 2001-08-27 | 35 | 0 |
| K011798 | CORERESTORE 2 | Sybron Dental Specialties, Inc. | 2001-08-14 | 67 | 0 |
| K010940 | SEALAPEX 4 | Sybron Dental Specialties, Inc. | 2001-06-20 | 83 | 1 |
| K003808 | TAKE 1 | Sybron Dental Specialties, Inc. | 2001-03-01 | 83 | 0 |
| K003640 | MINIENDO III | Sybron Dental Specialties, Inc. | 2001-02-22 | 87 | 0 |
| K003650 | PERMLASTIC 3 | Sybron Dental Specialties, Inc. | 2001-02-15 | 80 | 0 |
| K003658 | TEMP-BOND NE 2 | Sybron Dental Specialties, Inc. | 2001-01-04 | 37 | 0 |
| K001899 | IMPROVED TRY-IN GEL | Sybron Dental Specialties, Inc. | 2000-08-28 | 67 | 1 |
| K001881 | IMPROVED ENLIGHT LV | Sybron Dental Specialties, Inc. | 2000-08-22 | 62 | 0 |
| K001876 | TAKE 1 BITE | Sybron Dental Specialties, Inc. | 2000-07-21 | 31 | 0 |
| K000530 | BELLEGLASS HP ENAMEL | Sybron Dental Specialties, Inc. | 2000-05-17 | 90 | 0 |
| K000954 | KERR GEL ETCHANT | Sybron Dental Specialties, Inc. | 2000-04-28 | 35 | 0 |
| K000436 | BELLEGLASS HP TRANSLUCENT DENTIN | Sybron Dental Specialties, Inc. | 2000-03-24 | 43 | 0 |
| K000269 | BELLEGLASS HP OPACEOUS DENTIN | Sybron Dental Specialties, Inc. | 2000-03-23 | 55 | 0 |
| K994309 | SOLO ORTHO 2 | Sybron Dental Specialties, Inc. | 2000-03-17 | 87 | 0 |
| K992195 | QUANTEC-E IRRIGATION SYSTEM 2 | Sybron Dental Specialties, Inc. | 1999-10-08 | 101 | 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