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Orthometric Elastomerics - Elastic Positioner
FDA UDIEUDAMEDClass I (US FDA UDI)
by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda
Identity
- Trade Name
- ORTHOMETRIC ELASTOMERICS - ELASTIC POSITIONER FDA UDI
- Generic Name
- Orthodontic inter-arch elastic band FDA UDI
- Device Name
- ORTHODONTIC ELASTIC- LATEX- INTRA-ORAL POSITIONER FDA UDI
- Model / Reference
- 30.10.0127 FDA UDI
- Description
- ORTHODONTIC ELASTIC- LATEX- INTRA-ORAL POSITIONER FDA UDI
Identifiers
- Catalog Number
- 30.10.0127 FDA UDI
- Primary DI / UDI-DI
- 07908470707265 FDA UDI
- FDA Product Code
- ECI FDA UDI
- GMDN Term
- Orthodontic inter-arch elastic band FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 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
Yes
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 inter-arch elastic band
Orthometric Elastomerics - Elastic Positioner by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda — Class I — MDR, FDA UDI — listed…
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Also classified as Orthodontic inter-arch elastic band.
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- Relastics — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
Sources (2)
- FDA UDI efaac28b-27e4-47dc-b62c-f0065c2ea405 34 fields · synced May 31, 2026
- EUDAMED 1 fields · synced May 25, 2026