Data / Medical devices / Canada / W&H Impex Inc.
W&H Impex Inc.: FDA-registered device maker in Windsor Ontario, Canada, 34 510(k) clearances
W&H Impex Inc. is registered with the FDA (registration 3007279848) in Windsor Ontario, Canada. It lists 21 device types. The FDA files 34 510(k) clearances under its listings, the newest dated September 8, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007279848
- Address
- 6490 Hawthorne Drive, Windsor Ontario, Canada, N8T 1J9
- Owner or operator
- W&H Impex Inc. (10042701)
- Roles
- Exporter to the US
- First device listed
- December 19, 2012
- Registered through
- 2026
- Brand names listed
- Advanced Air System, Foot Control, Handpiece, Instrument Set BONE, Instrument Set PARO, Instrument Set SPECIAL, Instrument Set ENDO, Instrument Set EXTRACTION and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 8, 2026 | K261987 | Reusable SmartPeg | EKX | Substantially Equivalent | Osstell AB | accessdata.fda.gov |
| June 18, 2026 | K253776 | Implantmed Plus II & Piezomed Plus II Module | DZI | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| July 3, 2025 | K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) | ERL | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| February 28, 2025 | K242179 | Synea Fusion Handpieces (Intensiv & Profin) | EFB | Substantially Equivalent | W&H Dentalwerk Bürmoos GmbH | accessdata.fda.gov |
| February 8, 2024 | K233504 | Lexa MINI (RIS-303, RIS-305) | FLE | Substantially Equivalent | W&H Sterilization S.R.L. | accessdata.fda.gov |
| July 14, 2023 | K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530) | ELC | Substantially Equivalent | W&H Dentalwerk Buermoss GmbH | accessdata.fda.gov |
| May 5, 2023 | K223858 | Lexa MINI (RIS-303, RIS-305) | FLE | Substantially Equivalent | W&H Sterilization S.R.L. | accessdata.fda.gov |
| August 19, 2022 | K213758 | Lexa PLUS RIS-311 | FLE | Substantially Equivalent | W&H Sterilization S.R.L. | accessdata.fda.gov |
| May 26, 2022 | K213221 | AMADEO, M-UK1015 (incl. attachments and accessories) | ERL | Substantially Equivalent | W&H Dentalwerk Buermoss GmbH | accessdata.fda.gov |
| February 24, 2021 | K201703 | PROXEO Twist Cordless Polishing System PL-40 H | EKX | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| May 30, 2018 | K172825 | MN-111 | FLE | Substantially Equivalent | W&H Sterilization S.R.L. | accessdata.fda.gov |
| December 8, 2017 | K171553 | W&H Assistina Twin | EFB | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| February 23, 2017 | K162926 | Air-Powered Handpieces and Handpiece Attachments | EFB | Substantially Equivalent | W&H Dentalwerk Burmoos GmbH | accessdata.fda.gov |
| November 23, 2016 | K161957 | W&H Implantmed SI-1015 incl. Accessories | EBW | Substantially Equivalent | W&H Dentalwerk Burmoos GmbH | accessdata.fda.gov |
| November 23, 2015 | K143704 | Advanced Air System | EFB | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| October 16, 2014 | K133488 | PIEZOMED | DZI | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| May 28, 2014 | K133776 | A-DEC/W&H ELECTRIC HANDPIECE MOTOR | EBW | Substantially Equivalent | A-Dec, Inc. | accessdata.fda.gov |
| July 9, 2010 | K100647 | A-DEC/W&H SYNEA SONIC SCALER HANDPIECE, MODELS ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LM | ELC | Substantially Equivalent | A-Dec, Inc. | accessdata.fda.gov |
| July 9, 2010 | K100600 | PROSTHODONTIC SCREWDRIVER , MODEL IA-400 | EKX | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| December 15, 2009 | K090931 | CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR | EKX | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| January 15, 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 | EFB | Substantially Equivalent | A-Dec, Inc. | accessdata.fda.gov |
| July 29, 2008 | K080939 | SURGICAL HANDPIECES, MIKRO SAW HANDPIECES | KMW | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| July 5, 2007 | 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 | A-Dec, Inc. | accessdata.fda.gov |
| May 3, 2006 | K060287 | DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM | EBW | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| January 13, 2006 | K052741 | IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES | EBW | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| December 3, 2003 | K032572 | A-DEC/W&H ELECTRIC MOTOR, MODEL EA-50LT | EBW | Substantially Equivalent | A-Dec, Inc. | accessdata.fda.gov |
| May 3, 2002 | K014068 | ELCOMED, MODELS SA-200 C 230, SA-200 230, SA-200 C 115, SA-200 115 | EBW | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| October 5, 2001 | K010127 | W & H ASSISTINA | EFB | Substantially Equivalent | A-Dec, Inc. | accessdata.fda.gov |
| June 28, 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 | EGS | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| February 7, 2001 | K002469 | IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V) | EBW | Substantially Equivalent | W&H Dentalwerk Buermoos GmbH | accessdata.fda.gov |
| January 11, 2000 | K993526 | SYNEA - LS LOW-SPEED HANDPIECE | EFB | Substantially Equivalent | A-Dec, Inc. | accessdata.fda.gov |
| September 10, 1999 | K992011 | SYNEA-HS HIGH SPEED-HANDPIECE | EFB | Substantially Equivalent | A-Dec, Inc. | accessdata.fda.gov |
| August 25, 1995 | K944714 | W&H CORSAIR SCALER | EFB | Substantially Equivalent | A-Dec, Inc. | accessdata.fda.gov |
| August 25, 1995 | K944711 | W&H AIR MOTOR A25 | EFB | Substantially Equivalent | A-Dec, Inc. | accessdata.fda.gov |
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Updated September 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.