Identity
- Trade Name
- Paraband Tofflemire Matrix Bands FDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- Paraband Tofflemire Matrix Bands save time and improve the quality of restorations with their more conical formation. Direct Class II composites are simpler and faster to set up, often with no wedges or separating springs required. Restore teeth in a neutral, stable position with predictable broad and deep contacts. Large MODs will become routine. For direct Class III, IV and V composites, the band provides better isolation of the prep, as well as a stable matrix for condensing composite. Bonding to subgingival preparations is simpler due to the isolation and access provided. Works with any Tofflemire retainer. Precision-cut 0.0015" thin stainless steel. FDA UDI
- Model / Reference
- 7128310 FDA UDI
- Description
- Paraband Tofflemire Matrix Bands save time and improve the quality of restorations with their more conical formation. Direct Class II composites are simpler and faster to set up, often with no wedges or separating springs required. Restore teeth in a neutral, stable position with predictable broad and deep contacts. Large MODs will become routine. For direct Class III, IV and V composites, the band provides better isolation of the prep, as well as a stable matrix for condensing composite. Bonding to subgingival preparations is simpler due to the isolation and access provided. Works with any Tofflemire retainer. Precision-cut 0.0015" thin stainless steel. FDA UDI
Identifiers
- Catalog Number
- 71-28310 FDA UDI
- Primary DI / UDI-DI
- 00723896011065 FDA UDI
- FDA Product Code
- JEP FDA UDI
- GMDN Term
- Dental matrix band, single-use 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental matrix band, single-use
Paraband Tofflemire Matrix Bands by Practicon, Inc. — 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
- Practicon, Inc.
Sources (1)
- FDA UDI 1704d9c8-dc04-4498-ab62-f4e93bde5876 34 fields · synced Jun 8, 2026