FDA.reportPublic FDA data

E-FIBER

Primary DI
07898078659267
Brand
E-FIBER
Company
Angelus Industria de Produtos Odontologicos S A
Model
E-FIBER 5 cm 1.6 mm
Catalog number
4431
Device description
Fiberglass material used for the reinforcement of dental prostheses and the splinting of teeth.
Published
2025-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082180000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082180000PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440Angelus Industria DE Productos Odontologicos2008-12-17EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898078659267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898078659267078980786592677898078659267

GMDN Terms#

Term, Definition table
TermDefinition
Dental reinforcing fibreA device used in general restorative dentistry and orthodontic treatment typically as reinforcement of dental polymer-based materials, used for the construction of dental prostheses, i.e., splints, posts, crowns, and bridges. This device is typically made of polyethylene (PE) fibres supplied in strands, braid, or ribbon in a variety of sizes. It may also be used for the stabilization of avulsed teeth maintaining diastema closures or split-tooth syndrome. The ultrahigh molecular weight PE fibres increase the strength of composite materials, and provide improved safety by assisting in the retention of pieces in the event that a dental prosthesis is broken. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+554321013200sac@angelus.ind.br

Regulatory Flags#

DUNS number
906943303
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898078652961BIO-C REPAIR BIO-C REPAIR 1.5 g38812026-03-25
07898078659939Komet BioRepairKomet BioRepair 1.5 gBCR22024-11-26
07898078652701Komet BioRepairKomet BioRepair 0.5 gBCR12024-10-14
07898078650134SPEED GUNSPEED GUN 1 unit81812025-03-20
07898078657423SPEED GUNSPEED GUN Kit81802025-03-20
07898078659427EdgeUtopia RRM Dispensing GunEdgeUtopia RRM Dispensing Gun - 1 unit380602025-03-20
07898078659465PURE-Ca-SEAL PURE-Ca-SEAL 0.5 g39712025-03-20
07898078659236PERMA MESHPERMA MESH 1 unit44292025-02-17
07898078659243E-FIBERE-FIBER 10 cm 1.6 mm44302025-02-17
07898078659274E-FIBERE-FIBER 10 cm 1.2 mm44322025-02-17
07898078659281E-FIBERE-FIBER 5 cm 1.2 mm44332025-02-17
07898078659298E-FIBERE-FIBER 10 cm 1.4 mm44342025-02-17
07898078659403E-FIBERE-FIBER 5 cm 1.4 mm44352025-02-17
07898078656228MTA REPAIR HPMTA REPAIR HP 0.17 g8432020-11-09
07898078656648MTA REPAIR HPMTA REPAIR HP 0.425 g8462020-11-09
07898078658864BIO-C REPAIRBIO-C REPAIR 2 g38632020-11-05
07898078659823BIO-C SEALER ION+ BIO-C SEALER ION+ 2 g38432020-11-09
07898078659847BIO-C REPAIRBIO-C REPAIR 0.5 g38612020-11-05
07898078651605PURE-Ca-SEALPURE-Ca-SEAL 2 g39702024-10-14
07898078654996EdgeUtopia Repair Material EdgeUtopia Repair Material 0.25 g386302024-10-14

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