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Sign in to claim this brandHespeler Orthodontics Limited
US
Last updated May 23, 2026
What Hespeler Orthodontics Limited makes
Hespeler Orthodontics Limited manufactures orthodontic components, including metal brackets, nickel-titanium and stainless steel archwires, crimpable stops, buccal tubes, and self-ligating bracket tools. Their portfolio also includes protective sleeves for archwires, orthodontic pliers, power arms, locks, and accessories like compression hook kits and patient transfer systems. These products are designed for use in fixed orthodontic treatments, such as aligning teeth and managing wire tension.
All devices produced by the company fall under Class I regulatory classification in the US and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates within the United States, adhering to applicable regulatory requirements for orthodontic hardware.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Hespeler Orthodontics Limited manufacture?
Hespeler Orthodontics Limited specializes in orthodontic devices used in fixed dental treatments. Their product range includes metal orthodontic brackets, archwires made from nickel-titanium and stainless steel, crimpable stops, buccal tubes, and self-ligating bracket tools. They also produce accessories like archwire protection sleeves, orthodontic pliers, power arms, locks, and kits for patient transfers or compression hooks. These devices are primarily designed to align teeth, manage wire tension, and support orthodontic appliances during treatment.
Where is Hespeler Orthodontics Limited based, and what regulatory requirements do they follow?
Hespeler Orthodontics Limited is based in the United States. As a manufacturer of orthodontic hardware, their devices are subject to U.S. regulatory standards. Since all their products fall under Class I classification, they must comply with FDA requirements for medical devices, including registration, listing, and adherence to quality system regulations. Their devices are also included in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and transparency in the supply chain.
Which regulatory registries or databases list Hespeler Orthodontics Limited’s devices?
Hespeler Orthodontics Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each product has a standardized identifier for tracking, compliance, and transparency in the medical device supply chain. While the company itself may not be listed in broader manufacturer directories, their individual devices are accounted for in this official U.S. regulatory database.
How are Hespeler Orthodontics Limited’s orthodontic devices classified under U.S. regulations?
All of Hespeler Orthodontics Limited’s orthodontic devices are classified as Class I under U.S. regulations. This classification applies to low-risk devices that pose minimal potential harm to patients, such as brackets, archwires, and orthodontic tools. Class I devices typically require general controls (like proper labeling and manufacturing practices) rather than specialized premarket reviews, though they must still meet FDA registration and listing requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 203297635
Catalogue (101)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SPEED Supercable Kit | 07540295000345 | FDA UDI | N/A | Active |
| SPEED Single Buccal Tube | 75402950100115 | FDA UDI | Class I | Unknown |
| SPEED Lingual Supercable | 75402950300102 | FDA UDI | Class I | Unknown |
| SPEED Bracket | 75402950000019 | FDA UDI | Class I | Unknown |
| Trillium Compression Hook Kit | 75402950800039 | FDA UDI | N/A | Unknown |
| SPEED Buccal Tube Sample Kit | 75402950800077 | FDA UDI | N/A | Unknown |
| SPEED Beta Titanium Archwire | 75402950300010 | FDA UDI | Class I | Unknown |
| Trillium Compression Hook Pliers | 07540295000437 | FDA UDI | Class I | Active |
| SPEED Tubular Supercable | 07540295000215 | FDA UDI | Class I | Active |
| SPEED Tubular Supercable Kit | 75402950800022 | FDA UDI | N/A | Unknown |
| SPEED Split Hook | 75402950500045 | FDA UDI | Class I | Unknown |
| SPEED Convertible Buccal Tube | 07540295000109 | FDA UDI | Class I | Active |
| SPEED Bracket | 07540295000024 | FDA UDI | Class I | Active |
| SPEED Intra-Oral Reference Tool | 75402951100015 | FDA UDI | Class I | Unknown |
| SPEED Spring Clip | 07540295000338 | FDA UDI | Class I | Active |
| SPEED Double Buccal Tube | 75402950100153 | FDA UDI | Class I | Unknown |
| SPEED PE Mini Buccal Tube | 75402950100030 | FDA UDI | Class I | Unknown |
| SPEED Split Stop Sample Kit | 75402950400109 | FDA UDI | Class I | Unknown |
| SPEED Protector Coil | 75402950600011 | FDA UDI | Class I | Unknown |
| Hills Dual-Geometry Wire | 07540295000154 | FDA UDI | Class I | Active |
| SPEED Reinforcing Tube | 07540295000321 | FDA UDI | Class I | Active |
| Round Nickel Titanium Archwire | 75402950300065 | FDA UDI | Class I | Unknown |
| SPEED Archwire Hook Plier | 75402950900012 | FDA UDI | Class I | Unknown |
| SPEED Split Stop | 07540295000246 | FDA UDI | Class I | Active |
| Trillium Compression Hook | 75402950500137 | FDA UDI | Class I | Unknown |
| SPEED Hook | 07540295000284 | FDA UDI | Class I | Active |
| SPEED Coaxial Archwire | 07540295000123 | FDA UDI | Class I | Active |
| SPEED D-Wire - Stainless Steel | 75402950300041 | FDA UDI | Class I | Unknown |
| SPEED Convertible Buccal Tube | 07540295000086 | FDA UDI | Class I | Active |
| SPEED Buccal Tube | 07540295000055 | FDA UDI | Class I | Active |
| Trillium Compression Hook Pliers | 75402950900043 | FDA UDI | Class I | Unknown |
| SPEED Double Buccal Tube | 75402950100023 | FDA UDI | Class I | Unknown |
| SPEED Opening Instrument | 07540295000444 | FDA UDI | Class I | Active |
| SPEED Wire - Stainless Steel | 07540295000185 | FDA UDI | Class I | Active |
| SPEED Torquing Key | 07540295000468 | FDA UDI | Class I | Active |
| SPEED Convertible Buccal Tube | 75402950200013 | FDA UDI | Class I | Unknown |
| SPEED Bracket | 75402950000026 | FDA UDI | Class I | Unknown |
| SPEED Supercable Cutter | 07540295000413 | FDA UDI | Class I | Active |
| SPEED Split Stop Samples | 07540295000253 | FDA UDI | Class I | Active |
| SPEED Archwire Hook Plier | 07540295000406 | FDA UDI | Class I | Active |
| SPEED Intra-Oral Reference Tool | 07540295000451 | FDA UDI | Class I | Active |
| SPEED Lingual Supercable | 07540295000208 | FDA UDI | Class I | Active |
| SPEED Supercable | 07540295000192 | FDA UDI | Class I | Active |
| SPEED Supercable Cutter | 75402950900029 | FDA UDI | Class I | Unknown |
| SPEED Beta Titanium Archwire | 07540295000116 | FDA UDI | Class I | Active |
| SPEED Convertible Buccal Tube with Head Gear | 75402950200020 | FDA UDI | Class I | Unknown |
| SPEED Archwire Hook | 07540295000277 | FDA UDI | Class I | Active |
| SPEED Tubular Supercable | 75402950300119 | FDA UDI | Class I | Unknown |
| SPEED Buccal Tube Sample Kit | 75402950100108 | FDA UDI | Class I | Unknown |
| SPEED Opening Instrument | 75402951000018 | FDA UDI | Class I | Unknown |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Hespeler Orthodontics Limited CAMBRIDGE Ontario · CA FEI 3009955591