A-dec, Inc.
Newberg, OR, US
A-dec, Inc. appears in FDA device records in Newberg, OR. FDA records list 69 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 69FDA records hold 69 510(k) clearances for A-dec, Inc. between 1989 and 2022. The busiest year on record is 1993, with 18. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 2 |
| 1990 | 6 |
| 1991 | 2 |
| 1993 | 18 |
| 1994 | 6 |
| 1995 | 13 |
| 1996 | 2 |
| 1999 | 1 |
| 2000 | 4 |
| 2001 | 1 |
| 2003 | 5 |
| 2005 | 1 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 2 |
| 2010 | 2 |
| 2014 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213932 | A-dec 300, A-dec 500 | EIA | Substantially Equivalent | |
| K133776 | A-DEC/W&H ELECTRIC HANDPIECE MOTOR | EBW | Substantially Equivalent | |
| K102234 | A-DEC 200 DENTAL SYSTEM | EIA | Substantially Equivalent | |
| K100647 | A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM | ELC | Substantially Equivalent | |
| K082716 | A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43 | EFB | Substantially Equivalent | |
| K082827 | A-DEC/W&H PROFIN RECIPROCATING CONTRA-ANGLE HANDPIECE ATTACHMENT | EFB | Substantially Equivalent | |
| K082985 | A-DEC 334/335 DELIVERY SYSTEM | EIA | Substantially Equivalent | |
| K070663 | A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT | EFB | Substantially Equivalent | |
| K051657 | A-DEC SELF-CONTAINED WATER SYSTEM | EIA | Substantially Equivalent | |
| K032757 | A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE | EIA | Substantially Equivalent | |
| K032756 | A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533 | EIA | Substantially Equivalent | |
| K032572 | A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT | EBW | Substantially Equivalent | |
| K032070 | ELCACAM | EIA | Substantially Equivalent | |
| K022816 | W & H LISA STEAM STERILIZER | FLE | Substantially Equivalent | |
| K010127 | W & H ASSISTINA | EFB | Substantially Equivalent | |
| K000968 | 3181 DUO DELIVERY SYSTEM | EIA | Substantially Equivalent | |
| K000967 | 4635 ASSISTANT'S INSTRUMENTATION | EIA | Substantially Equivalent | |
| K000966 | 4631 DUO DELIVERY SYSTEM | EIA | Substantially Equivalent | |
| K993526 | SYNEA - LS LOW-SPEED HANDPIECE | EFB | Substantially Equivalent | |
| K992011 | SYNEA-HS HIGH SPEED-HANDPIECE | EFB | Substantially Equivalent | |
| K962665 | A-DEC SELF-CONTAINED WATER SYSTEM | EIA | Substantially Equivalent | |
| K960506 | A-DEC PERFORMER CONTROL UNIT | EIA | Substantially Equivalent | |
| K945734 | W&H ROTO QUICK COUPLINGS | EFB | Substantially Equivalent | |
| K944719 | W&H 100 SERIES LOW SPEED | EFB | Substantially Equivalent | |
| K944718 | W&H 900 INCOLIGHT LT HANDPIECE | EFB | Substantially Equivalent | |
| K944713 | W&H MICRO AIR MOTOR LT25 | EFB | Substantially Equivalent | |
| K944714 | W&H CORSAIR SCALER | EFB | Substantially Equivalent | |
| K944712 | W&H MICRO MOTOR E25 (WITHOUT LIGHT) | EFB | Substantially Equivalent | |
| K944711 | W&H AIR MOTOR A25 | EFB | Substantially Equivalent | |
| K944709 | W&H 896 TOP LIGH HIGHSPEED | EFB | Substantially Equivalent | |
| K944717 | W&H 798 TOP AIR TURBINE TRIPLE SPRAY | EFB | Substantially Equivalent | |
| K944716 | W&H 796 TOP AIR TURBINE MINI-HEAD | EFB | Substantially Equivalent | |
| K944715 | W&H 795 TOP AIR TURBINE SINGLE SPRAY | EFB | Substantially Equivalent | |
| K944710 | W&H 898 TOP LIGHT HIGHSPEED | EFB | Substantially Equivalent | |
| K944708 | W&H 895 TOP LIGH HIGHSPEED FIBEROPTIC SINGLE SPRAY | EFB | Substantially Equivalent | |
| K940893 | A-DEC RADIUS 2122/2132 | EIA | Substantially Equivalent | |
| K935325 | A-DEC CASCADE 3072 WALLMOUNT | EIA | Substantially Equivalent | |
| K925367 | A-DEC 7284 CUSPIDOR, CASCADE | EBR | Substantially Equivalent | |
| K925119 | A-DEC 1040 CHAIR | KLC | Substantially Equivalent | |
| K925798 | A-DEC 2545 DUO IC MICRO-CART | EIA | Substantially Equivalent | |
| K925797 | A-DEC 2544 DOCTORS IC MICRO-CART | EIA | Substantially Equivalent | |
| K925325 | A-DEC 2185 DOCTOR'S UNIT | KLC | Substantially Equivalent | |
| K925324 | A-DEC 2184 DUO UNIT | KLC | Substantially Equivalent | |
| K925323 | A-DEC 2183 DUO UNIT, CUSP | KLC | Substantially Equivalent | |
| K925322 | A-DEC 2147 DOCTOR'S UNIT | KLC | Substantially Equivalent | |
| K925321 | A-DEC 2146 DUO UNIT | KLC | Substantially Equivalent | |
| K925320 | A-DEC 2145 DUO UNIT, CUSP | KLC | Substantially Equivalent | |
| K925319 | A-DEC 2182 DOCTOR'S UNIT | KLC | Substantially Equivalent | |
| K925318 | A-DEC 2181 DUO UNIT | KLC | Substantially Equivalent | |
| K925317 | A-DEC 2180 DUO UNIT, CUSP | KLC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015729 | 3015729 | A-dec, Inc. | 2601 Crestview Drive, Newberg, OR 97132 US | 2026 | and 14 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LYUAccessory, Surgical Apparel
- EHAAligner, Beam, X-Ray
- KLCChair, Dental, With Operative Unit
- NRUChair, Dental, Without Operative Unit
- EBWController, Foot, Handpiece And Cord
- QYJDental Waterline Treatment Cartridge
- LRJDisinfectant, Medical Devices
- EHZEvacuator, Oral Cavity
- EFBHandpiece, Air-Powered, Dental
- EFAHandpiece, Belt And/Or Gear Driven, Dental
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- EKXHandpiece, Direct Drive, Ac-Powered
- QJKIntraoral Camera
- FTDLamp, Surgical
- NTKLight Transmission Caries Detector
- EAZLight, Operating, Dental
- NBLLight-Induced Fluorescence Caries Detector
- LQYLocator, Root Apex
- DYNMouthpiece, Saliva Ejector
- ELCScaler, Ultrasonic
- FLESterilizer, Steam
- EIAUnit, Operative Dental
- NRDUnit, Operative Dental, Accessories
- EBRUnit, Suction Operatory
- ECBUnit, Syringe, Air And/Or Water
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0541-2011 | A-dec Decade Plus 1221 Dental Chair This chair is used for positioning dental patient prior to and during dental treatment. | The design of the Decade Plus 1221 chair backrest creates a possible pinch-point between the chair backrest and the underside of the armrests. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain