Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Coltene/Whaledent, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
178 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071632 | PERFECT TISSUE CONTOURING SYSTEM II | Coltene/Whaledent, Inc. | 2007-10-18 | 126 | 0 |
| K051660 | DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION S | Coltene/Whaledent, Inc. | 2005-08-04 | 43 | 0 |
| K040551 | COLTOLUX LED CURING LIGHT | Coltene/Whaledent, Inc. | 2004-03-15 | 13 | 0 |
| K033760 | ONE COAT SE BOND | Coltene/Whaledent, Inc. | 2004-01-23 | 52 | 0 |
| K031752 | COLTOSOL F | Coltene/Whaledent, Inc. | 2003-08-05 | 61 | 0 |
| K013400 | SYNERGY FLOW | Coltene/Whaledent, Inc. | 2001-12-10 | 56 | 0 |
| K003034 | COLTENE AURA COMPOMER RESTORATIVE SYSTEM | Coltene/Whaledent, Inc. | 2000-11-30 | 63 | 0 |
| K993545 | TENAX WHITE POST | Coltene/Whaledent, Inc. | 2000-04-14 | 178 | 0 |
| K000311 | PARAPOST FIBER WHITE | Coltene/Whaledent, Inc. | 2000-03-14 | 42 | 0 |
| K993710 | MODIFICATION OF PARAPOST CEMENT | Coltene/Whaledent, Inc. | 1999-12-21 | 48 | 0 |
| K993835 | PARAPOST SYSTEM STERILIZABLE ORGANIZER | Coltene/Whaledent, Inc. | 1999-12-16 | 34 | 0 |
| K993255 | BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE | Coltene/Whaledent, Inc. | 1999-12-06 | 69 | 0 |
| K983727 | BIOSONIC ULTRASONIC SCALER SYSTEM | Coltene/Whaledent, Inc. | 1999-01-20 | 90 | 0 |
| K974906 | ONE COAT BOND DENTIN/ENAMEL ADHESIVE SYSTEM | Coltene/Whaledent, Inc. | 1998-03-24 | 83 | 0 |
| K974465 | SYNERGY | Coltene/Whaledent, Inc. | 1998-03-09 | 103 | 0 |
| K950106 | COLTOLUX LIGHT METER | Coltene/Whaledent, Inc. | 1995-05-24 | 133 | 0 |
| K945698 | COLTOLUX 3, COLTOLUX 4 | Coltene/Whaledent, Inc. | 1995-05-24 | 188 | 0 |
| K945366 | PARAPOST CEMENT | Coltene/Whaledent, Inc. | 1995-02-02 | 104 | 0 |
| K934192 | PARAPOST XT SYSTEM | Coltene/Whaledent, Inc. | 1994-06-06 | 284 | 0 |
| K922615 | COLTENE A.R.T. BOND | Coltene/Whaledent, Inc. | 1992-08-03 | 62 | 0 |
| K912485 | COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC | Coltene/Whaledent, Inc. | 1991-07-25 | 51 | 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