Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A-Dec, Inc. — Predicate Candidate Screening
69 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
137 daysmedian FDA review time
414 days90th percentile
69clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213932 | A-dec 300, A-dec 500 | A-Dec, Inc. | 2022-03-02 | 76 | 0 |
| K133776 | A-DEC/W&H ELECTRIC HANDPIECE MOTOR | A-Dec, Inc. | 2014-05-28 | 167 | 0 |
| K102234 | A-DEC 200 DENTAL SYSTEM | A-Dec, Inc. | 2010-11-24 | 107 | 0 |
| K100647 | A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 | A-Dec, Inc. | 2010-07-09 | 123 | 0 |
| K082716 | A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97 | A-Dec, Inc. | 2009-01-15 | 120 | 0 |
| K082827 | A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACH | A-Dec, Inc. | 2009-01-07 | 104 | 0 |
| K082985 | A-DEC 334/335 DELIVERY SYSTEM | A-Dec, Inc. | 2008-12-17 | 71 | 0 |
| K070663 | A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, | A-Dec, Inc. | 2007-07-05 | 118 | 0 |
| K051657 | A-DEC SELF-CONTAINED WATER SYSTEM | A-Dec, Inc. | 2005-08-30 | 70 | 0 |
| K032757 | A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & | A-Dec, Inc. | 2003-12-10 | 96 | 0 |
| K032756 | A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 | A-Dec, Inc. | 2003-12-04 | 90 | 0 |
| K032572 | A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT | A-Dec, Inc. | 2003-12-03 | 105 | 0 |
| K032070 | ELCACAM | A-Dec, Inc. | 2003-08-27 | 55 | 0 |
| K022816 | W & H LISA STEAM STERILIZER | A-Dec, Inc. | 2003-02-07 | 165 | 0 |
| K010127 | W & H ASSISTINA | A-Dec, Inc. | 2001-10-05 | 275 | 0 |
| K000966 | 4631 DUO DELIVERY SYSTEM | A-Dec, Inc. | 2000-05-03 | 37 | 0 |
| K000968 | 3181 DUO DELIVERY SYSTEM | A-Dec, Inc. | 2000-05-03 | 37 | 0 |
| K000967 | 4635 ASSISTANT'S INSTRUMENTATION | A-Dec, Inc. | 2000-05-03 | 37 | 0 |
| K993526 | SYNEA - LS LOW-SPEED HANDPIECE | A-Dec, Inc. | 2000-01-11 | 85 | 0 |
| K992011 | SYNEA-HS HIGH SPEED-HANDPIECE | A-Dec, Inc. | 1999-09-10 | 87 | 0 |
| K962665 | A-DEC SELF-CONTAINED WATER SYSTEM | A-Dec, Inc. | 1996-08-22 | 44 | 0 |
| K960506 | A-DEC PERFORMER CONTROL UNIT | A-Dec, Inc. | 1996-03-25 | 49 | 0 |
| K944719 | W&H 100 SERIES LOW SPEED | A-Dec, Inc. | 1995-10-05 | 377 | 0 |
| K945734 | W&H ROTO QUICK COUPLINGS | A-Dec, Inc. | 1995-10-05 | 316 | 0 |
| K944718 | W&H 900 INCOLIGHT LT HANDPIECE | A-Dec, Inc. | 1995-10-05 | 377 | 0 |
| K944713 | W&H MICRO AIR MOTOR LT25 | A-Dec, Inc. | 1995-08-28 | 339 | 0 |
| K944711 | W&H AIR MOTOR A25 | A-Dec, Inc. | 1995-08-25 | 336 | 0 |
| K944712 | W&H MICRO MOTOR E25 (WITHOUT LIGHT) | A-Dec, Inc. | 1995-08-25 | 336 | 0 |
| K944714 | W&H CORSAIR SCALER | A-Dec, Inc. | 1995-08-25 | 336 | 0 |
| K944709 | W&H 896 TOP LIGH HIGHSPEED | A-Dec, Inc. | 1995-06-08 | 258 | 0 |
| K944710 | W&H 898 TOP LIGHT HIGHSPEED | A-Dec, Inc. | 1995-06-02 | 252 | 0 |
| K944717 | W&H 798 TOP AIR TURBINE TRIPLE SPRAY | A-Dec, Inc. | 1995-06-02 | 252 | 0 |
| K944708 | W&H 895 TOP LIGH HIGHSPEED FIBEROPTIC SINGLE SPRAY | A-Dec, Inc. | 1995-06-02 | 252 | 0 |
| K944715 | W&H 795 TOP AIR TURBINE SINGLE SPRAY | A-Dec, Inc. | 1995-06-02 | 252 | 0 |
| K944716 | W&H 796 TOP AIR TURBINE MINI-HEAD | A-Dec, Inc. | 1995-06-02 | 252 | 0 |
| K940893 | A-DEC RADIUS 2122/2132 | A-Dec, Inc. | 1994-07-12 | 137 | 0 |
| K935325 | A-DEC CASCADE 3072 WALLMOUNT | A-Dec, Inc. | 1994-04-21 | 167 | 0 |
| K925367 | A-DEC 7284 CUSPIDOR, CASCADE | A-Dec, Inc. | 1994-04-11 | 537 | 0 |
| K925119 | A-DEC 1040 CHAIR | A-Dec, Inc. | 1994-01-31 | 479 | 0 |
| K925797 | A-DEC 2544 DOCTORS IC MICRO-CART | A-Dec, Inc. | 1994-01-06 | 416 | 0 |
| K925798 | A-DEC 2545 DUO IC MICRO-CART | A-Dec, Inc. | 1994-01-06 | 416 | 0 |
| K925325 | A-DEC 2185 DOCTOR'S UNIT | A-Dec, Inc. | 1993-12-09 | 414 | 0 |
| K925323 | A-DEC 2183 DUO UNIT, CUSP | A-Dec, Inc. | 1993-12-09 | 414 | 0 |
| K925320 | A-DEC 2145 DUO UNIT, CUSP | A-Dec, Inc. | 1993-12-09 | 414 | 0 |
| K925316 | A-DEC 2172 DOCTOR'S UNIT | A-Dec, Inc. | 1993-12-09 | 414 | 0 |
| K925318 | A-DEC 2181 DUO UNIT | A-Dec, Inc. | 1993-12-09 | 414 | 0 |
| K925319 | A-DEC 2182 DOCTOR'S UNIT | A-Dec, Inc. | 1993-12-09 | 414 | 0 |
| K925321 | A-DEC 2146 DUO UNIT | A-Dec, Inc. | 1993-12-09 | 414 | 0 |
| K925317 | A-DEC 2180 DUO UNIT, CUSP | A-Dec, Inc. | 1993-12-09 | 414 | 0 |
| K925324 | A-DEC 2184 DUO UNIT | A-Dec, Inc. | 1993-12-09 | 414 | 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