Identity
- Trade Name
- ADITEK FDA UDI
- Generic Name
- Self-ligating orthodontic bracket FDA UDI
- Device Name
- Bracket Ceramic Translux 018 Ricketts U4/5 Hk 0°T 0°A w/1 FDA UDI
- Model / Reference
- 05.02.0916 FDA UDI
- Description
- Bracket Ceramic Translux 018 Ricketts U4/5 Hk 0°T 0°A w/1 FDA UDI
Identifiers
- Catalog Number
- 05.02.0916 FDA UDI
- Primary DI / UDI-DI
- 07899439273528 FDA UDI
- FDA Product Code
- NJM FDA UDI
- GMDN Term
- Self-ligating orthodontic bracket FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Self-ligating orthodontic bracket
The ADITEK self-ligating orthodontic bracket is a ceramic device designed to hold an orthodontic archwire in place, providing a secure and adjustable system for teeth alignment. With its integral fixation clip and polymer-hinge design, this single-patient device is suitable for use in single-use applications during dental treatment.
Similar devices
Also classified as Self-ligating orthodontic bracket.
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- ECLIPSE PASSIVE — ORTHO ARCH COMPANY INC · Class I
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- ECLIPSE PASSIVE — ORTHO ARCH COMPANY INC · Class I
- RCM-18-503 — GNI Co., Ltd · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Aditek Do Brasil S/A
Sources (1)
- FDA UDI 36e584cc-ddf4-4521-8e52-ce4fd5d72ce1 34 fields · synced Jul 26, 2026