Identity
- Trade Name
- Bioclear Evolve FDA UDI
- Generic Name
- Dental matrix band, single-use FDA UDI
- Device Name
- Clear matrix used in dental restorations. FDA UDI
- Model / Reference
- Blue 5mm FDA UDI
- Description
- Clear matrix used in dental restorations. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D949327012251 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
Bioclear Evolve by Bioclear Matrix Systems, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental matrix band, single-use.
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- Prehma — Keystone Industries · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- Cure-Thru Clear Cervical Matrices — PREMIER DENTAL PRODUCTS COMPANY · Class I
- JMU — JMU DENTAL, INC · 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
- Bioclear Matrix Systems, LLC
Sources (1)
- FDA UDI 129d5f03-b5b2-4720-9391-c5917a505ad9 33 fields · synced Jun 8, 2026