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Orthometric Pro Aligner X
FDA UDIClass I (US FDA UDI)
by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda
Identity
- Trade Name
- ORTHOMETRIC PRO ALIGNER X FDA UDI
- Generic Name
- Orthodontic progressive aligner FDA UDI
- Device Name
- ALIGNER SHEETS - PRO ALIGNER X – Ø 125 X 1 MM- PCT 10 UN FDA UDI
- Model / Reference
- 30.11.0067 FDA UDI
- Description
- ALIGNER SHEETS - PRO ALIGNER X – Ø 125 X 1 MM- PCT 10 UN FDA UDI
Identifiers
- Catalog Number
- 30.11.0067 FDA UDI
- Primary DI / UDI-DI
- 07908470707197 FDA UDI
- FDA Product Code
- KMY FDA UDI
- GMDN Term
- Orthodontic progressive aligner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5525 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
Yes
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
No
FDA UDI
Category: Orthodontic progressive aligner
Orthometric Pro Aligner X by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda — Class I — FDA UDI — listed in FDA GUDID
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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
Sources (1)
- FDA UDI 447d0603-eaff-46cd-9e09-49832531949c 34 fields · synced May 30, 2026