FDA.reportPublic FDA data

ACTEON

Primary DI
03760243000010
Brand
ACTEON
Company
ACTEON MANUFACTURING
Model
BIOSPLINT RIBBON
Catalog number
201661
Device description
Ribbon for stabilization of mobile teeth
Published
2016-09-24
Public version status
Update
Distribution status
Not 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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760243000010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760243000010037602430000103760243000010

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
+33556340607info@acteongroup.com

Regulatory Flags#

DUNS number
283473691
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760243001048ACTEONEXPASYL EXACT2020-03-04
03760243000430Art by RISKONTROLRISKONTROL2017002022-09-20
03760243000492Classic by RISKONTROLRISKONTROL2016642022-09-20
03760243000508Classic by RISKONTROLRISKONTROL2016652022-09-20
03760243000515Classic by RISKONTROLRISKONTROL2016662022-09-20
03760243000522Classic by RISKONTROLRISKONTROL2016672022-09-20
03760243000539Classic by RISKONTROLRISKONTROL2016682022-09-20
03760243000546Total protec by RISKONTROLRISKONTROL2017502022-09-20
03760243000706EXPASYL x20EXPASYL2610302022-09-20
03760243000713EXPASYL strawberry flavor EXPASYL2610012022-09-20
03760243000720Expasyl cannulasEXPASYL2610402022-09-20
03760243000737Expasyl cannulasEXPASYL2610052022-09-20
03760243000744Expasyl cannulasEXPASYL2610452022-09-20
03760243000751Expasyl cannulasEXPASYL2610152022-09-20
03760243001093Classic by RISKONTROLRISKONTROL2016692025-04-01
03760243005008EXPASYL x6EXPASYL2940102022-09-20
03760243000027ADAPTATER RISKONTROL ADEC INOXRISKONTROL2001952024-03-21
03760243000089ADAPTATER RISKONTROL DCIRISKONTROL2001522024-03-21
03760243000263ADAPTATER RISKONTROL LU INOXRISKONTROL2001502024-03-21
03760243000270ADAPTATER RISKONTROL LU NEW INOXRISKONTROL2001992024-03-21

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