Identity
- Trade Name
- ADITEK FDA UDI
- Generic Name
- Orthodontic appliance dimension gauge FDA UDI
- Device Name
- EasyClip+ Opening Tool OT FDA UDI
- Model / Reference
- 00.01.0004 FDA UDI
- Description
- EasyClip+ Opening Tool OT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07899439298385 FDA UDI
- FDA Product Code
- ECP FDA UDI
- GMDN Term
- Orthodontic appliance dimension gauge FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
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 appliance dimension gauge
Aditek by Aditek Do Brasil S/A — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- SCHWERT — A. Schweickhardt GmbH & Co. KG · Class I
- Precision Dental Instruments — Precision Dental Instruments · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Aditek Do Brasil S/A
Sources (1)
- FDA UDI 81d44ca8-faa8-4610-976b-69053b27f43d 33 fields · synced May 31, 2026