Registered with FDA
W&H Impex Inc.
Windsor, Canada. Lists 10 dental device types with FDA across 1 registered establishment.
- Device types listed
- 10
- Brands and models
- 16
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Canada
Devices listed with FDA
What W&H Impex Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Lister | Advanced Air System | 2021 |
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Lister | — | 2013 |
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Lister | Foot ControlInstrument changerInstrument Set BONEInstrument Set ENDOInstrument Set EXTRACTIONInstrument Set PAROInstrument Set SPECIAL | 2014 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Lister | Handpiece | 2013 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Lister | Foot ControlInstrument changerInstrument Set BONEInstrument Set ENDOInstrument Set EXTRACTIONInstrument Set PAROInstrument Set SPECIAL | 2014 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Lister | — | 2023 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Lister | — | 2013 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | — | 2023 |
| Rotary Bone Cutting HandpieceKMW · Class 2 | Surgical drills & motors | Lister | — | 2013 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Lister | — | 2012 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
W&H Impex Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: W&H Dentalwerk Buermoos GmbH (13), A-dec, Inc. (10), W&H Dentalwerk Bürmoos GmbH (3), Osstell AB (1), W&H Dentalwerk Buermoss GmbH (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 8 Sep 2026 | K261987 | Reusable SmartPeg | Osstell AB | EKX Ac-Powered Direct Drive Handpiece |
| 18 Jun 2026 | K253776 | Implantmed Plus II & Piezomed Plus II Module | W&H Dentalwerk Buermoos GmbH | DZI Powered Bone Drill |
| 28 Feb 2025 | K242179 | Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH | EFB Dental Air-Powered Handpiece |
| 14 Jul 2023 | K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530) | W&H Dentalwerk Buermoss GmbH | ELC Ultrasonic Scaler |
| 24 Feb 2021 | K201703 | PROXEO Twist Cordless Polishing System PL-40 H | W&H Dentalwerk Buermoos GmbH | EKX Ac-Powered Direct Drive Handpiece |
| 8 Dec 2017 | K171553 | W&H Assistina Twin | W&H Dentalwerk Buermoos GmbH | EFB Dental Air-Powered Handpiece |
| 23 Feb 2017 | K162926 | Air-Powered Handpieces and Handpiece Attachments | W&H Dentalwerk Bürmoos GmbH | EFB Dental Air-Powered Handpiece |
| 23 Nov 2016 | K161957 | W&H Implantmed SI-1015 incl. Accessories | W&H Dentalwerk Bürmoos GmbH | EBW Handpiece and Cord Foot Controller |
| 23 Nov 2015 | K143704 | Advanced Air System | W&H Dentalwerk Buermoos GmbH | EFB Dental Air-Powered Handpiece |
| 16 Oct 2014 | K133488 | PIEZOMED | W&H Dentalwerk Buermoos GmbH | DZI Powered Bone Drill |
| 28 May 2014 | K133776 | A-DEC/W&H ELECTRIC HANDPIECE MOTOR | A-dec, Inc. | EBW Handpiece and Cord Foot Controller |
| 9 Jul 2010 | K100647 | A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM | A-dec, Inc. | ELC Ultrasonic Scaler |
| 9 Jul 2010 | K100600 | PROSTHODONTIC SCREWDRIVER , MODEL IA-400 | W&H Dentalwerk Buermoos GmbH | EKX Ac-Powered Direct Drive Handpiece |
| 15 Dec 2009 | K090931 | CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR | W&H Dentalwerk Buermoos GmbH | EKX Ac-Powered Direct Drive Handpiece |
| 15 Jan 2009 | 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 | A-dec, Inc. | EFB Dental Air-Powered Handpiece |
| 29 Jul 2008 | K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | W&H Dentalwerk Buermoos GmbH | KMW Rotary Bone Cutting Handpiece |
| 5 Jul 2007 | K070663 | A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT | A-dec, Inc. | EFB Dental Air-Powered Handpiece |
| 3 May 2006 | K060287 | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM | W&H Dentalwerk Buermoos GmbH | EBW Handpiece and Cord Foot Controller |
| 13 Jan 2006 | K052741 | IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES | W&H Dentalwerk Buermoos GmbH | EBW Handpiece and Cord Foot Controller |
| 3 Dec 2003 | K032572 | A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT | A-dec, Inc. | EBW Handpiece and Cord Foot Controller |
| 3 May 2002 | K014068 | ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 | W&H Dentalwerk Buermoos GmbH | EBW Handpiece and Cord Foot Controller |
| 5 Oct 2001 | K010127 | W & H ASSISTINA | A-dec, Inc. | EFB Dental Air-Powered Handpiece |
| 28 Jun 2001 | K011061 | SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11 | W&H Dentalwerk Buermoos GmbH | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 7 Feb 2001 | K002469 | IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) | W&H Dentalwerk Buermoos GmbH | EBW Handpiece and Cord Foot Controller |
| 11 Jan 2000 | K993526 | SYNEA - LS LOW-SPEED HANDPIECE | A-dec, Inc. | EFB Dental Air-Powered Handpiece |
| 10 Sep 1999 | K992011 | SYNEA-HS HIGH SPEED-HANDPIECE | A-dec, Inc. | EFB Dental Air-Powered Handpiece |
| 25 Aug 1995 | K944714 | W&H CORSAIR SCALER | A-dec, Inc. | EFB Dental Air-Powered Handpiece |
| 25 Aug 1995 | K944711 | W&H AIR MOTOR A25 | A-dec, Inc. | EFB Dental Air-Powered Handpiece |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| W&H IMPEX INC.FDA reg. 3007279848 | Windsor Ontario, Canada | Foreign exporter |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042701). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.