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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 2601 Crestview Drive, Newberg, OR, 97132
- Website
- a-dec.com
- —
- —
- [email protected]
- Phone
- 5035389471
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3015729
- DUNS Number
- 009617473
Catalogue (329)
Page 6 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| A-dec | 300AVS | FDA UDI | Class I | Active |
| A-dec | 11.1136.00 | FDA UDI | Class I | Active |
| A-dec | 533A | FDA UDI | Class I | Unknown |
| A-dec | 77.1100.01 | FDA UDI | Class I | Active |
| A-dec | 54.0875.00 | FDA UDI | Class I | Active |
| A-dec | 200ASA | FDA UDI | Class I | Active |
| A-dec | 336 | FDA UDI | Class I | Active |
| A-dec | 311 | FDA UDI | Class I | Active |
| A-dec | 54.0877.00 | FDA UDI | Class I | Active |
| A-dec | 311FLT | FDA UDI | Class I | Active |
| A-dec | 200DSA | FDA UDI | Class I | Active |
| A-Dec 2181 Duo Unit | K925318 | FDA 510(k) | Class I | Active |
| A-Dec Self-Contained Water System, Model 0.7 Liter Bottle & 2 Liter Bottle | K032757 | FDA 510(k) | Class I | Active |
| A-Dec Decade 1015 Chair | K903450 | FDA 510(k) | Class I | Active |
| Synea - Ls Low-Speed Handpiece | K993526 | FDA 510(k) | Class I | Active |
| 4631 Duo Delivery System | K000966 | FDA 510(k) | Class I | Active |
| W&H 898 Top Light Highspeed | K944710 | FDA 510(k) | Class I | Active |
| A-Dec Kneebreak 1030 Chair | K913059 | FDA 510(k) | Class I | Active |
| A-Dec Decade 1010 Chair | K903454 | FDA 510(k) | Class I | Active |
| W&H 896 Top Ligh Highspeed | K944709 | FDA 510(k) | Class I | Active |
| W&H 798 Top Air Turbine Triple Spray | K944717 | FDA 510(k) | Class I | Active |
| A-Dec 2184 Duo Unit | K925324 | FDA 510(k) | Class I | Active |
| A-Dec 2612 Assistant's Cart | K933163 | FDA 510(k) | Class I | Active |
| A-Dec Performer Control Unit | K960506 | FDA 510(k) | Class I | Active |
| A-Dec 1040 Chair | K925119 | FDA 510(k) | Class I | Active |
| A-Dec Self-Contained Water System | K962665 | FDA 510(k) | Class I | Active |
| A-Dec/W&H Electric Motor, Model Ea-50lt | K032572 | FDA 510(k) | Class I | Active |
| Elcacam | K032070 | FDA 510(k) | Class I | Active |
| W&H 796 Top Air Turbine Mini-Head | K944716 | FDA 510(k) | Class I | Active |
| A-Dec 2185 Doctor's Unit | K925325 | FDA 510(k) | Class I | Active |
| W & H Lisa Steam Sterilizer | K022816 | FDA 510(k) | Class II | Active |
| A-Dec 532/533 Delivery System Model, 532/533 | K032756 | FDA 510(k) | Class I | Active |
| A-Dec Radius 2122/2132 | K940893 | FDA 510(k) | Class I | Active |
| A-Dec 2182 Doctor's Unit | K925319 | FDA 510(k) | Class I | Active |
| W&H Micro Air Motor Lt25 | K944713 | FDA 510(k) | Class I | Active |
| A-Dec 2180 Duo Unit, Cusp | K925317 | FDA 510(k) | Class I | Active |
| A-Dec/W&H Electric Handpiece Motor | K133776 | FDA 510(k) | Class I | Active |
| A-Dec 7284 Cuspidor, Cascade | K925367 | FDA 510(k) | Class I | Active |
| A-Dec 2147 Doctor's Unit | K925322 | FDA 510(k) | Class I | Active |
| A-Dec Pac I Portable Unit | K903451 | FDA 510(k) | Class I | Active |
| W&H 895 Top Ligh Highspeed Fiberoptic Single Spray | K944708 | FDA 510(k) | Class I | Active |
| A-Dec 2172 Doctor's Unit | K925316 | FDA 510(k) | Class I | Active |
| W&H Micro Motor E25 (without Light) | K944712 | FDA 510(k) | Class I | Active |
| A-Dec Decade Cuspidor | K903455 | FDA 510(k) | Class I | Active |
| Synea-Hs High Speed-Handpiece | K992011 | FDA 510(k) | Class I | Active |
| A-Dec Self-Contained Water System | K051657 | FDA 510(k) | Class I | Active |
| A-Dec 2912 Duo Cart | K933167 | FDA 510(k) | Class I | Active |
| A-Dec Cascade 3072 Wallmount | K935325 | FDA 510(k) | Class I | Active |
| 4635 Assistant's Instrumentation | K000967 | FDA 510(k) | Class I | Active |
| W&H 900 Incolight Lt Handpiece | K944718 | FDA 510(k) | Class I | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 1, 2009 | Z-0541-2011 | — | terminated | The design of the Decade Plus 1221 chair backrest creates a possible pinch-point between the chair backrest and the underside of the armrests. |