Identity
- Trade Name
- E-FIBER FDA UDI
- Generic Name
- Dental reinforcing fibre FDA UDI
- Device Name
- Fiberglass material used for the reinforcement of dental prostheses and the splinting of teeth. FDA UDI
- Model / Reference
- E-FIBER 10 cm 1.6 mm FDA UDI
- Description
- Fiberglass material used for the reinforcement of dental prostheses and the splinting of teeth. FDA UDI
Identifiers
- Catalog Number
- 4430 FDA UDI
- Primary DI / UDI-DI
- 07898078659243 FDA UDI
- 510(k) Number
- K082180 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental reinforcing fibre
E-Fiber by Angelus Industria de Produtos Odontologicos S A — 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
Cleared under the same submission
K082180 also covers:
- E-FIBER — Angelus Industria de Produtos Odontologicos S A
- E-FIBER — Angelus Industria de Produtos Odontologicos S A
- E-FIBER — Angelus Industria de Produtos Odontologicos S A
- E-FIBER — Angelus Industria de Produtos Odontologicos S A
- E-FIBER — Angelus Industria de Produtos Odontologicos S A
- PERMA MESH — Angelus Industria de Produtos Odontologicos S A
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
- Angelus Industria de Produtos Odontologicos S A
Sources (1)
- FDA UDI 5dfad8b5-b3e9-4879-a057-956e6d76ab8d 36 fields · synced May 30, 2026