Identity
- Trade Name
- eFiber FDA UDI
- Generic Name
- Dental reinforcing fibre FDA UDI
- Device Name
- eFiber Perio Kit. Kit contains. 2 eFiber 1.2mm Perio (00842092112519) . 1 F8 Silicone Cutter (00842092112069) FDA UDI
- Model / Reference
- 7009052 FDA UDI
- Description
- eFiber Perio Kit. Kit contains. 2 eFiber 1.2mm Perio (00842092112519) . 1 F8 Silicone Cutter (00842092112069) FDA UDI
Identifiers
- Catalog Number
- 7009052 FDA UDI
- Primary DI / UDI-DI
- 00842092155929 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental reinforcing fibre
eFiber by PREAT Corporation — 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
- Infibra — BIOLOREN SRL · 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
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
- PREAT Corporation
Sources (1)
- FDA UDI 81ea34dd-573c-4acf-a857-669c2fe44738 35 fields · synced May 31, 2026