Identity
- Trade Name
- Maquira FDA UDI
- Generic Name
- Dental abrasive strip, single-use FDA UDI
- Device Name
- The Polyester Abrasive Strips Airon aims at finishing and polishing of dental restorations. The functioning of the polyester sandpaper strip is mechanical, i.e. because it is composed of an abrasive material that when rubbing against the restored tooth surface, promotes abrasion/wear and polishing of the tooth region. FDA UDI
- Model / Reference
- Box containing 150 units of Polyester Abrasive Strips Airon (4 x 170 mm) FDA UDI
- Description
- The Polyester Abrasive Strips Airon aims at finishing and polishing of dental restorations. The functioning of the polyester sandpaper strip is mechanical, i.e. because it is composed of an abrasive material that when rubbing against the restored tooth surface, promotes abrasion/wear and polishing of the tooth region. FDA UDI
Identifiers
- Catalog Number
- 80322400058 FDA UDI
- Primary DI / UDI-DI
- 07898561540270 FDA UDI
- FDA Product Code
- EHM FDA UDI
- GMDN Term
- Dental abrasive strip, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6010 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
Yes
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: Dental abrasive strip, single-use
Maquira by Maquira Industria de Produtos Odontologicos S/A — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Manufacturer
- Maquira Industria de Produtos Odontologicos S/A
Sources (1)
- FDA UDI d32e6a5d-60e7-468e-98e8-d4df2863a5fc 34 fields · synced Jun 8, 2026