Manufacturer registered with FDA
Hespeler Orthodontics Ltd
CAMBRIDGE, Canada. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 998
- 510(k) clearances
- 0as applicant
- Markets registered in
- 662 registrations outside the US
- Establishments
- 1Canada
Registered in 6 markets
Where regulators' registries name Hespeler Orthodontics Ltd as the manufacturer or the registration holder of a device.
RegisteredHome: CanadaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Hespeler Orthodontics Ltd | 6 device types | — | Below |
| Canada | Health Canada | Registration holder | HESPELER ORTHODONTICS LIMITED | 48 | 1999–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Hespeler Orthodontics Limited | 6 | 2011–2012 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Hespeler Orthodontics Limited | 6 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Hespeler Orthodontics Ltd | 1 | 2008–2008 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Hespeler Orthodontics Limited | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Hespeler Orthodontics Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | COAXPF16COAXPF18DNTAW18X18LLDNTAW18X18LMDNTAW18X18LSDNTAW18X18ULDNTAW18X18UMDNTAW18X18USDNTAW21X21LLDNTAW21X21LM 120 moreDNTAW21X21LSDNTAW21X21ULDNTAW21X21UMDNTAW21X21USDSSAW18X18LLDSSAW18X18LMDSSAW18X18LSDSSAW18X18ULDSSAW18X18UMDSSAW18X18USDSSAW21X21LLDSSAW21X21LMDSSAW21X21LSDSSAW21X21ULDSSAW21X21UMDSSAW21X21USHARSSAW18X18X17X26MMLLHARSSAW18X18X17X26MMLMHARSSAW18X18X17X26MMLSHARSSAW18X18X17X28MMLLHARSSAW18X18X17X28MMLMHARSSAW18X18X17X28MMLSHARSSAW18X18X17X34MMULHARSSAW18X18X17X34MMUMHARSSAW18X18X17X34MMUSHARSSAW18X18X17X38MMULHARSSAW18X18X17X38MMUMHARSSAW18X18X17X38MMUSHARSSAW21X21X18X26MMLLHARSSAW21X21X18X26MMLMHARSSAW21X21X18X26MMLSHARSSAW21X21X18X28MMLLHARSSAW21X21X18X28MMLMHARSSAW21X21X18X28MMLSHARSSAW21X21X18X34MMULHARSSAW21X21X18X34MMUMHARSSAW21X21X18X34MMUSHARSSAW21X21X18X38MMULHARSSAW21X21X18X38MMUMHARSSAW21X21X18X38MMUSHDGAW18X18X18X26MMLLHDGAW18X18X18X26MMLMHDGAW18X18X18X26MMLSHDGAW18X18X18X28MMLLHDGAW18X18X18X28MMLMHDGAW18X18X18X28MMLSHDGAW18X18X18X34MMULHDGAW18X18X18X34MMUMHDGAW18X18X18X34MMUSHDGAW18X18X18X38MMULHDGAW18X18X18X38MMUMHDGAW18X18X18X38MMUSHDGAW21X21X20X26MMLLHDGAW21X21X20X26MMLMHDGAW21X21X20X26MMLSHDGAW21X21X20X28MMLLHDGAW21X21X20X28MMLMHDGAW21X21X20X28MMLSHDGAW21X21X20X34MMULHDGAW21X21X20X34MMUMHDGAW21X21X20X34MMUSHDGAW21X21X20X38MMULHDGAW21X21X20X38MMUMHDGAW21X21X20X38MMUSLSC16LSC18NTR14LMNTR14UMNTR16LMNTR16UMNTR18LMNTR18UMNTR20LMNTR20UMSBTAW18X22LLSBTAW18X22LMSBTAW18X22LSSBTAW18X22SLSBTAW18X22ULSBTAW18X22UMSBTAW18X22USSBTAW20X20LLSBTAW20X20LMSBTAW20X20LSSBTAW20X20SLSBTAW20X20ULSBTAW20X20UMSBTAW20X20USSC16SC18SC20SCKITSNTAW17X22LLSNTAW17X22LMSNTAW17X22LSSNTAW17X22ULSNTAW17X22UMSNTAW17X22USSNTAW20X25LLSNTAW20X25LMSNTAW20X25LSSNTAW20X25ULSNTAW20X25UMSNTAW20X25USSSSAW17X22LLSSSAW17X22LMSSSAW17X22LSSSSAW17X22ULSSSAW17X22UMSSSAW17X22USSSSAW20X25LLSSSAW20X25LMSSSAW20X25LSSSSAW20X25ULSSSAW20X25UMSSSAW20X25USTSC16TSC18TSC20TSCKIT | 2015 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | BUCCAL TUBE KIT 18BUCCAL TUBE KIT 22CSTKIT18L6-10CSTKIT18L6-24CSTKIT18L7-10CSTKIT18U6-10CSTKIT18U6-1045CSTKIT18U6-10WCSTKIT18U7-10CSTKIT22L6-10 328 moreCSTKIT22L6-24CSTKIT22L7-10CSTKIT22L7-28CSTKIT22U6-10CSTKIT22U6-1045CSTKIT22U7-10RE TUBES 1.5MMRE TUBES 10.5MMRE TUBES 10MMRE TUBES 11MMRE TUBES 12MMRE TUBES 13MMRE TUBES 14MMRE TUBES 15MMRE TUBES 16MMRE TUBES 18MMRE TUBES 2 MMRE TUBES 20MMRE TUBES 5.5MMRE TUBES 7MMRE TUBES 8.5MMRE TUBES 8MMRE TUBES 9.5MMRE TUBES 9MM18LL6-10CST18LL6-10CSTW18LL6-10DT18LL6-10DTDW18LL6-10DTLH18LL6-10DTW18LL6-10DTWLH18LL6-10DTWXLH18LL6-10DTXLH18LL6-10ST18LL6-10STDW18LL6-10STLH18LL6-10STW18LL6-10STWLH18LL6-10STWXLH18LL6-10STXLH18LL6-24CST18LL6-24CSTW18LL6-24DT18LL6-24DTLH18LL6-24DTW18LL6-24DTWLH18LL6-24DTWXLH18LL6-24DTXLH18LL6-24ST18LL6-24STDW18LL6-24STLH18LL6-24STW18LL6-24STWLH18LL6-24STWXLH18LL6-24STXLH18LL7-10CST18LL7-10ST18LL7-10STLH18LL7-10STPE18LL7-10STXLH18LL7-28CST18LL7-28ST18LL7-28STLH18LL7-28STPE18LL7-28STXLH18LR6-10CST18LR6-10CSTW18LR6-10DT18LR6-10DTDW18LR6-10DTLH18LR6-10DTW18LR6-10DTWLH18LR6-10DTWXLH18LR6-10DTXLH18LR6-10ST18LR6-10STDW18LR6-10STLH18LR6-10STW18LR6-10STWLH18LR6-10STWXLH18LR6-10STXLH18LR6-24CST18LR6-24CSTW18LR6-24DT18LR6-24DTLH18LR6-24DTW18LR6-24DTWLH18LR6-24DTWXLH18LR6-24DTXLH18LR6-24ST18LR6-24STDW18LR6-24STLH18LR6-24STW18LR6-24STWLH18LR6-24STWXLH18LR6-24STXLH18LR7-10CST18LR7-10ST18LR7-10STLH18LR7-10STPE18LR7-10STXLH18LR7-28CST18LR7-28ST18LR7-28STLH18LR7-28STPE18LR7-28STXLH18UL6-10CST18UL6-10CSTHG4518UL6-10CSTHG5118UL6-10CSTW18UL6-10CSTWHG4518UL6-10CSTWHG5118UL6-10DT18UL6-10DTDW18UL6-10DTDWLH18UL6-10DTLH18UL6-10DTW18UL6-10DTWLH18UL6-10DTWXLH18UL6-10DTXLH18UL6-10ST18UL6-10STDW18UL6-10STDWLH18UL6-10STLH18UL6-10STW18UL6-10STWLH18UL6-10STWXLH18UL6-10STXLH18UL7-10CST18UL7-10CSTW18UL7-10ST18UL7-10STDW18UL7-10STDWLH18UL7-10STLH18UL7-10STW18UL7-10STWLH18UL7-10STWXLH18UL7-10STXLH18UL7-28ST18UR6-10CST | 2015 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | IK OPENING INST.OPENING INST.SCCUTTERSCRULERTK18TK22 | 2015 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | AWH21X21DCRIM STOPS 1.5MMCRIM STOPS 2MMF1F2TAWH KITTAWHL16-18X22RECTTAWHL18-19X25RECTTAWHL18SQTAWHL24-22X16RECT 5 moreTAWHL25X17-18RECTTAWHM24-22X16RECTTAWHM25X17-18RECTTAWHS24-22X16RECTTAWHS25X17-18RECT | 2022 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | AWH16RDAWH16X22RECTAWH17X22SPEEDAWH17X25RECTAWH18RDAWH18SQAWH18X18DAWH18X22RECTAWH19X25RECTAWH20RD 494 moreAWH20X25SPEEDAWH21SQF1-F1+F2-F2+F3-F3+F5-F5+LRG SPLIT HOOKSLRG SPLIT STOPSMED SPLIT HOOKSMED SPLIT STOPSNSEP1/4DSCPROTECTORSPLIT STOP KITTAWHL16RDTAWHL16SQTAWHL18RDTAWHL20RDTAWHL21SQTAWHL21X25RECTTAWHM14RDTAWHM16-18X22RECTTAWHM16RDTAWHM16SQTAWHM18-19X25RECTTAWHM18RDTAWHM18SQTAWHM20RDTAWHM21SQTAWHM21X25RECTTAWHS14RDTAWHS16-18X22RECTTAWHS16RDTAWHS16SQTAWHS18-19X25RECTTAWHS18RDTAWHS18SQTAWHS20RDTAWHS21SQTAWHS21X25RECTWSEP1/4D18LL1-1LNG18LL1-1RPR18LL1-1RPRM-18LL1-6RPR18LL1-6RPRM-18LL1+5RPR18LL1+5RPRM-18LL2-1LNG18LL2-1RPR18LL2-1RPRM-18LL2-6RPR18LL2-6RPRM-18LL2-8RPR18LL2-8RPRM-18LL2+3RPR18LL2+3RPRM-18LL3-1LNG18LL3-4WR18LL3-4WRM-18LL3-7WR18LL3-7WRM-18LL3+7WR18LL3+7WRM-18LL4-0WR18LL4-0WRM-18LL4-11WR18LL4-11WRM-18LL4-4WR18LL4-4WRM-18LL5-0HRF18LL5-0HRFM-18LL5-0WR18LL5-0WRM-18LL5-17HRF18LL5-17HRFM-18LL5-17WR18LL5-17WRM-18LL5-8HRF18LL5-8HRFM-18LL5-8WR18LL5-8WRM-18LL6-22BT18LL6-22BTM-18LL6-22BTM-W18LL6-22BTW18LL6-22WR18LL6-22WRM-18LL7-22BT18LL7-22BTM-18LL7-22WR18LL7-22WRM-18LR1-1LNG18LR1-1RPR18LR1-1RPRM+18LR1-6RPR18LR1-6RPRM+18LR1+5RPR18LR1+5RPRM+18LR2-1LNG18LR2-1RPR18LR2-1RPRM+18LR2-6RPR18LR2-6RPRM+18LR2-8RPR18LR2-8RPRM+18LR2+3RPR18LR2+3RPRM+18LR3-1LNG18LR3-4WR18LR3-4WRM+18LR3-7WR18LR3-7WRM+18LR3+7WR18LR3+7WRM+18LR4-0WR18LR4-0WRM+18LR4-11WR18LR4-11WRM+18LR4-4WR18LR4-4WRM+18LR5-0HRF18LR5-0HRFM+18LR5-0WR18LR5-0WRM+18LR5-17HRF18LR5-17HRFM+18LR5-17WR18LR5-17WRM+18LR5-8HRF18LR5-8HRFM+18LR5-8WR18LR5-8WRM+18LR6-22BT18LR6-22BTM+18LR6-22BTM+W18LR6-22BTW | 1997 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | AWHPLIERHGHP-02HGHP-02KHGHP-02RSCSPLIT STOP PLIER | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HESPELER ORTHODONTICS LIMITEDFDA reg. 9615289 | CAMBRIDGE Ontario, Canada | Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9027395). 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.