FDA.reportPublic FDA data

Dentapreg® Braid

Primary DI
08595652700504
Brand
Dentapreg® Braid
Company
ADM, a.s.
Model
D-602
Published
2016-11-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952353000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952353000EZ-COMPAdm, Inc.1995-08-10EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08595652700504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08595652700504085956527005048595652700504

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

Regulatory Flags#

DUNS number
360589469
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08595652700672Fibrafill® DENTINF-004F-0042021-12-10
08595652700689Fibrafill® FLOWF-005F-0052021-12-10
08595652700726Fibrafill® DENTIN SampleF-104F-1042021-12-10
08595652700733Fibrafill® FLOW SampleF-105F-1052021-12-10
08595652700641Fibrafill® CUBE SF-001F-0012021-04-13
08595652700696Fibrafill® CUBE S SampleF-101F-1012021-04-13
08595652700252Dentapreg® PINPost smallD-402D-4022017-03-28
08595652700269Dentapreg® PINPost largeD-404D-4042017-03-28
08595652700283Dentapreg® SFM SplintingD-501D-5012016-11-22
08595652700290Dentapreg® PFM Anterior BridgeD-502D-5022016-11-22
08595652700306Dentapreg® PFU Posterior BridgeD-5032016-11-22
08595652700313Dentapreg® UFM CrownD-5042016-11-22
08595652700320Dentapreg® SFU ReinforcementD-5052016-11-22
08595652700481Dentapreg® INTROD-5602016-11-22
08595652700498Dentapreg® BundleD-6012016-11-22
08595652700511Dentapreg® VeilD-6032016-11-22
08595652700528Dentapreg® MESH Pink 3 pcs.D-6042016-11-22
08595652700542Dentapreg® MESH Pink SingleD-6062016-11-22
08595652700566Dentapreg® MESH Pink Economy PackD-6092016-11-22

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