FDA.reportPublic FDA data

GlasSpan Dental Fiber

Primary DI
D844G314
Brand
GlasSpan Dental Fiber
Company
GLASSPAN INC
Model
Large Rope
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing
ELSSplint, Endodontic Stabilizing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2
ELSSplint, Endodontic StabilizingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D844G314PrimaryHIBCC0
D844G303Unit of UseHIBCC0

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
610-363-7573JAlan@glasspan.com

Regulatory Flags#

DUNS number
838967594
Device count
3

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D844G112GlasSpan Dental FiberSmall Rope2016-09-21
D844G213GlasSpan Dental FiberMedium Rope2016-09-21
D844G415GlasSpan Dental FiberTape2016-09-19

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