Is this your brand? Sign in to claim ownership.
Sign in to claim this brandALLESEE AOA-PRO
US
Last updated May 24, 2026
What ALLESEE AOA-PRO makes
The company manufactures custom-made and self-removable orthodontic appliances, including metal clasps, retainers, and palate expanders, as well as bonded screw-based expanders and habit-breaking appliances. Their portfolio also includes removable occlusal splints and associated accessories like spacers, crimpable components, and mechanisms for orthodontic adjustments.
These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable regulatory requirements for dental and orthodontic products.
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 Allesee AOA-Pro manufacture?
Allesee AOA-Pro specializes in orthodontic devices, focusing on custom-made and self-removable appliances. Their portfolio includes metal orthodontic clasps, retainers, palate expanders (both self-removable and bonded), habit-breaking appliances, and removable occlusal splints. They also produce accessories like spacers, crimpable components, and mechanisms for orthodontic adjustments, such as the Activator, Flip Lock Spacers, and MiniScope mechanisms.
Where is Allesee AOA-Pro based, and what regulatory framework does it follow?
Allesee AOA-Pro is based in the United States. As a manufacturer of orthodontic devices, it operates under U.S. regulatory requirements, including compliance with FDA guidelines for dental and orthodontic products. Their devices are listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and monitor authorized medical devices in the market.
Which FDA device classes apply to Allesee AOA-Pro’s products, and why?
Allesee AOA-Pro’s devices are classified under FDA’s Class I and Class II categories. Class I generally includes low-risk devices like some orthodontic accessories (e.g., spacers or crimpable components), while Class II applies to moderate-risk devices such as bonded palate expanders or habit-breaking appliances, which require additional controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and regulatory history.
Are Allesee AOA-Pro’s devices listed in any regulatory registries, and if so, which ones?
Yes, Allesee AOA-Pro’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry tracks authorized medical devices in the U.S. by assigning a standardized identifier to each product, improving transparency, traceability, and compliance monitoring. Listing in the UDI database is a requirement for many FDA-regulated devices to ensure proper identification and reporting.
How are Allesee AOA-Pro’s orthodontic appliances categorized in terms of customization?
Allesee AOA-Pro manufactures both custom-made and self-removable orthodontic appliances. Custom-made devices are tailored to a patient’s specific dental structure, such as metal clasps or bonded palate expanders, while self-removable options—like certain palate expanders or retainers—are designed to be taken out by the patient for cleaning or comfort. This flexibility allows for varied clinical applications depending on patient needs and treatment plans.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- aoalab.com
- —
- —
- [email protected]
- Phone
- +12628861050
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 158312728
Catalogue (166)
Page 2 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| MARA Elbow, Long, left | MATER31D | FDA UDI | Class I | Active |
| TS Accessories | MATER98B | FDA UDI | Class I | Active |
| 5mm Round Spacer, Pk/10 | MATER11 | FDA UDI | Class I | Active |
| HTH Mechanism 24mm, Set | MATER92 | FDA UDI | Class I | Active |
| Herbst Bite Jumper | 3000-0010 | FDA UDI | Class I | Active |
| MARA Accessories | 1704-0035 | FDA UDI | Class I | Active |
| 2mm TS Spacer, Pk/10 | MATER125 | FDA UDI | Class I | Active |
| Prezurv | 3000-0130 | FDA UDI | Class I | Active |
| Nord Expander | 3000-0020 | FDA UDI | Class I | Active |
| Flip Lock Lower Piston Caps, Pk/10 | MATER 93A | FDA UDI | Class I | Active |
| Flip Lock, Damon on Arch Wire, Pk/5 | MATER88A | FDA UDI | Class I | Active |
| ACCO Expander | 3000-0018 | FDA UDI | Class I | Active |
| Herbst Flip-Lock Accessories | 1704-8000 | FDA UDI | Class I | Active |
| MDA Appliance | 3000-0094 | FDA UDI | Class I | Active |
| Mora-Gelb Splint | 3000-0122 | FDA UDI | Class I | Active |
| Flip Lock Upper Ball Comfort Caps, Pk/10 | MATER93 | FDA UDI | Class I | Active |
| HTH Accessories | MATER96 | FDA UDI | Class I | Active |
| Arnold Expander | 3000-0052 | FDA UDI | Class I | Active |
| 18mm TS Mechanism, set | MATER106 | FDA UDI | Class I | Active |
| 4mm Hex Screw, Pk/10 | MATRE05 | FDA UDI | Class I | Active |
| 1mm Round Spacer, Pk/2 | MATER67A | FDA UDI | Class I | Active |
| Flip Lock Sleeve, Right | MATER82 | FDA UDI | Class I | Active |
| HTH Mechanism 21mm | MATER77C | FDA UDI | Class I | Active |
| Rapid Palatal Expander | 3000-0040 | FDA UDI | Class I | Active |
| Red, White and Blue Retainer | 3000-0004 | FDA UDI | Class II | Active |
| Pendex | 3000-0092 | FDA UDI | Class I | Active |
| Shamey Expander | 3000-0019 | FDA UDI | Class I | Active |
| Simpli5 | 3000-0005 | FDA UDI | Class II | Active |
| Repositioning Splint | 3000-0123 | FDA UDI | Class I | Active |
| 5.5mm Comfort Cap, Pk/10 | MATER12A | FDA UDI | Class I | Active |
| Palatal Thumb Crib | 3000-0071 | FDA UDI | Class I | Active |
| HTH Mechanism 16mm | MATER77A | FDA UDI | Class I | Active |
| 2mm Flip Lock Spacer, Pk/2 | MATER68B | FDA UDI | Class I | Active |
| Herbst Sleeve, Right | MATER74A | FDA UDI | Class I | Active |
| HTH Mechanism 24mm | MATER77D | FDA UDI | Class I | Active |
| 24mm TS Mechanism, set | MATER109 | FDA UDI | Class I | Active |
| 2mm Round Spacer, Pk/2 | MATER67B | FDA UDI | Class I | Active |
| Flip Lock Sleeve, Left | MATER82A | FDA UDI | Class I | Active |
| Damon Retention Splint | 3000-0126 | FDA UDI | Class I | Active |
| Quad Helix | 3000-0041 | FDA UDI | Class I | Active |
| Mclr | 3000-0031 | FDA UDI | Class I | Active |
| Archwire Extender, .022, Pk/10 | MATER34 | FDA UDI | Class I | Active |
| MARA Elbow, Short, right | MATER29A | FDA UDI | Class I | Active |
| 1mm Round Spacer, Pk/10 | MATER07 | FDA UDI | Class I | Active |
| Hayrake-Palatal with Spurs | 3000-0073 | FDA UDI | Class I | Active |
| Bluegrass Tongue Trainer | 3000-0072 | FDA UDI | Class I | Active |
| Band and Loop Space Maintainer | 3000-0035 | FDA UDI | Class I | Active |
| Hex Appliance | 3000-0095 | FDA UDI | Class I | Active |
| Flip Lock Pistons, Pk/2 | MATER80 | FDA UDI | Class I | Active |
| Twin Block | 3000-0016 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.