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Aditek
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 01.01.0003Model Dental accesories
Identity
- Trade Name
- Stop 3mm w/10 EUDAMEDADITEK FDA UDI
- Generic Name
- Orthodontic bracket, metal FDA UDI
- Device Name
- Stop 3mm w/10 FDA UDI
- Model / Reference
- 01.01.0003 EUDAMEDFDA UDIDental accesories EUDAMED
- Description
- Stop 3mm w/10 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07899439252875 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07899439252875 EUDAMED
- FDA Product Code
- EJF FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic bracket, metal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic bracket, metal
Aditek by Aditek Do Brasil S/A — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic bracket, metal.
- Mini-Mono® — Forestadent Bernhard Förster GmbH · Class I
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- LEGEND — GC Orthodontics America Inc. · Class I
- MIRABAY — MIRABAY ORTHODONTICS CORPORATION · Class I
- RMO — RMO · Class I
- Mini-Mono® — Forestadent Bernhard Förster GmbH · Class I
- Votion — ORTHO TECHNOLOGY, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Aditek Do Brasil S/A
Sources (2)
- FDA UDI c53d76f3-a669-46b1-9deb-830706c34f60 33 fields · synced Jul 13, 2026
- EUDAMED a6640f64-dada-4d22-81df-8b99685ac865 61 fields · synced Jul 13, 2026