Identity
- Trade Name
- Infibra FDA UDI
- Generic Name
- Dental reinforcing fibre FDA UDI
- Device Name
- Spool, 1 mm, refill FDA UDI
- Model / Reference
- IF1 FDA UDI
- Description
- Spool, 1 mm, refill FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056099230011 FDA UDI
- 510(k) Number
- K061735 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental reinforcing fibre FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Height — 1 Millimeter FDA UDI
Category: Dental reinforcing fibre
Infibra by Bioloren Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental reinforcing fibre.
- GlasSpan Flexible Ceramic Bonding Rope Large Refill — PRACTICON, INC. · Class II
- everStick® — Gc America Inc. · Class II
- everStick® — Gc America Inc. · Class II
- ENFORCE FRC™ — G&H Wire Company, Inc. · Class II
- Brasseler USA — Peter Brasseler Holdings, LLC · Class II
- everStick® — Gc America Inc. · Class II
- Dentapreg® INTRO — ADM, a.s. · Class II
- GlasSpan Dental Fiber — GLASSPAN INC · Class II
Cleared under the same submission
K061735 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bioloren Srl
Sources (1)
- FDA UDI 88eed2dc-2307-4268-88f0-59c0cc797667 35 fields · synced Jun 6, 2026