A-Dec, Inc.
Medical device manufacturer in Newberg, OR.
69510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K213932 | A-dec 300, A-dec 500EIA · Traditional | 03/02/2022SE |
| K133776 | A-Dec/W&H Electric Handpiece MotorEBW · Special | 05/28/2014SE |
| K102234 | A-Dec 200 Dental SystemEIA · Traditional | 11/24/2010SE |
| K100647 | A-Dec/W&H Synea Sonic Scaler Handpiece, Models ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LMELC · Traditional | 07/09/2010SE |
| K082716 | A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98, A-Dec/W&H Alegra…EFB · Abbreviated | 01/15/2009SE |
| K082827 | A-Dec/W&H Profin Reciprocating Contra-Angle Handpiece AttachmentEFB · Abbreviated | 01/07/2009SE |
| K082985 | A-Dec 334/335 Delivery SystemEIA · Traditional | 12/17/2008SE |
| K070663 | A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, A-Dec/W&H Synea…EFB · Abbreviated | 07/05/2007SE |
| K051657 | A-Dec Self-Contained Water SystemEIA · Traditional | 08/30/2005SE |
| K032757 | A-Dec Self-Contained Water System, Model 0.7 Liter Bottle & 2 Liter BottleEIA · Traditional | 12/10/2003SE |
| K032756 | A-Dec 532/533 Delivery System Model, 532/533EIA · Traditional | 12/04/2003SE |
| K032572 | A-Dec/W&H Electric Motor, Model EA-50LTEBW · Traditional | 12/03/2003SE |
| K032070 | ElcacamEIA · Traditional | 08/27/2003SE |
| K022816 | W & H Lisa Steam SterilizerFLE · Abbreviated | 02/07/2003SE |
| K010127 | W & H AssistinaEFB · Traditional | 10/05/2001SE |
| K000968 | 3181 Duo Delivery SystemEIA · Traditional | 05/03/2000SE |
| K000967 | 4635 Assistant's InstrumentationEIA · Traditional | 05/03/2000SE |
| K000966 | 4631 Duo Delivery SystemEIA · Traditional | 05/03/2000SE |
| K993526 | Synea - LS Low-Speed HandpieceEFB · Traditional | 01/11/2000SE |
| K992011 | Synea-Hs High Speed-HandpieceEFB · Traditional | 09/10/1999SE |
| K962665 | A-Dec Self-Contained Water SystemEIA · Traditional | 08/22/1996SE |
| K960506 | A-Dec Performer Control UnitEIA · Traditional | 03/25/1996SE |
| K945734 | W&H Roto Quick CouplingsEFB · Traditional | 10/05/1995SE |
| K944719 | W&H 100 Series Low SpeedEFB · Traditional | 10/05/1995SE |
| K944718 | W&H 900 Incolight LT HandpieceEFB · Traditional | 10/05/1995SE |
| K944713 | W&H Micro Air Motor LT25EFB · Traditional | 08/28/1995SE |
| K944714 | W&H Corsair ScalerEFB · Traditional | 08/25/1995SE |
| K944712 | W&H Micro Motor E25 (Without Light)EFB · Traditional | 08/25/1995SE |
| K944711 | W&H Air Motor A25EFB · Traditional | 08/25/1995SE |
| K944709 | W&H 896 Top Ligh HighspeedEFB · Traditional | 06/08/1995SE |
| K944717 | W&H 798 Top Air Turbine Triple SprayEFB · Traditional | 06/02/1995SE |
| K944716 | W&H 796 Top Air Turbine Mini-HeadEFB · Traditional | 06/02/1995SE |
| K944715 | W&H 795 Top Air Turbine Single SprayEFB · Traditional | 06/02/1995SE |
| K944710 | W&H 898 Top Light HighspeedEFB · Traditional | 06/02/1995SE |
| K944708 | W&H 895 Top Ligh Highspeed Fiberoptic Single SprayEFB · Traditional | 06/02/1995SE |
| K940893 | A-Dec Radius 2122/2132EIA · Traditional | 07/12/1994SE |
| K935325 | A-Dec Cascade 3072 WallmountEIA · Traditional | 04/21/1994SE |
| K925367 | A-Dec 7284 Cuspidor, CascadeEBR · Traditional | 04/11/1994SE |
| K925119 | A-Dec 1040 ChairKLC · Traditional | 01/31/1994SE |
| K925798 | A-Dec 2545 Duo Ic Micro-CartEIA · Traditional | 01/06/1994SE |
| K925797 | A-Dec 2544 Doctors Ic Micro-CartEIA · Traditional | 01/06/1994SE |
| K925325 | A-Dec 2185 Doctor's UnitKLC · Traditional | 12/09/1993SE |
| K925324 | A-Dec 2184 Duo UnitKLC · Traditional | 12/09/1993SE |
| K925323 | A-Dec 2183 Duo Unit, CuspKLC · Traditional | 12/09/1993SE |
| K925322 | A-Dec 2147 Doctor's UnitKLC · Traditional | 12/09/1993SE |
| K925321 | A-Dec 2146 Duo UnitKLC · Traditional | 12/09/1993SE |
| K925320 | A-Dec 2145 Duo Unit, CuspKLC · Traditional | 12/09/1993SE |
| K925319 | A-Dec 2182 Doctor's UnitKLC · Traditional | 12/09/1993SE |
| K925318 | A-Dec 2181 Duo UnitKLC · Traditional | 12/09/1993SE |
| K925317 | A-Dec 2180 Duo Unit, CuspKLC · Traditional | 12/09/1993SE |
| K925316 | A-Dec 2172 Doctor's UnitKLC · Traditional | 12/09/1993SE |
| K925315 | A-Dec 2171 Duo UnitKLC · Traditional | 12/09/1993SE |
| K925314 | A-Dec 2170 Duo Unit CuspKLC · Traditional | 12/09/1993SE |
| K931137 | Dental Syringe TipECB · Traditional | 11/29/1993SE |
| K933166 | A-Dec 2611 Assistant's CartEIA · Traditional | 10/20/1993SE |
| K933167 | A-Dec 2912 Duo CartEIA · Traditional | 10/13/1993SE |
| K933168 | A-Dec 3127 Assistant's WallmountEIA · Traditional | 10/12/1993SE |
| K933165 | A-Dec 3131 Duo Wallmount (with Instrumentation)EIA · Traditional | 10/12/1993SE |
| K933163 | A-Dec 2612 Assistant's CartEIA · Traditional | 10/12/1993SE |
| K913535 | A-Dec Decade 1020 ChairKLC · Traditional | 10/09/1991SE |
| K913059 | A-Dec Kneebreak 1030 ChairKLC · Traditional | 10/08/1991SE |
| K903455 | A-Dec Decade CuspidorEIA · Traditional | 10/24/1990SE |
| K903454 | A-Dec Decade 1010 ChairKLC · Traditional | 10/24/1990SE |
| K903453 | A-Dec Ic Micro-CartEIA · Traditional | 10/24/1990SE |
| K903452 | A-Dec Ic Control HeadEIA · Traditional | 10/24/1990SE |
| K903451 | A-Dec Pac I Portable UnitEIA · Traditional | 10/24/1990SE |
| K903450 | A-Dec Decade 1015 ChairKLC · Traditional | 10/24/1990SE |
| K893045 | A-Dec Priority 1005 ChairKLC · Traditional | 07/14/1989SE |
| K893044 | A-Dec Dental LightEAZ · Traditional | 07/14/1989SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0541-2011 | A-dec Decade Plus 1221 Dental Chair This chair is used for positioning dental patient…The design of the Decade Plus 1221 chair backrest creates a possible pinch-point between the chair backrest… | 04/01/2009Terminated |