FDA.report

breCAM.BioHPP TU

Primary DI
EBRE540T21019
Brand
breCAM.BioHPP TU
Company
bredent GmbH & Co. KG
Model
540T2101
Catalog number
540T2101
Device description
breCAM.BioHPP TU Ø 95 x 20mm ZZ dentin-shade 2 1 Piece
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EBFMATERIAL, TOOTH SHADE, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EBRE540T21019PackageHIBCC1Not in Commercial Distribution
EBRE540T21010PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental bridge, polymerA custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of polymer-based material, with or without fibre reinforcement, and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00keep dry
Special Storage Condition, Specify00keep out of sunlight

Sterilization Methods

Method

Contacts

PhoneEmail
+4907309872451info@bredent.com

Regulatory Flags

DUNS number
341086190
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
EBREVLCOLBLACK9visio.lign color BlackVLCOLBLACKVLCOLBLACK2025-03-10
EBREVLCOLBLUE9visio.lign color BlueVLCOLBLUEVLCOLBLUE2025-03-10
EBREVLCOLBODYA9visio.lign color Body AVLCOLBODYAVLCOLBODYA2025-03-10
EBREVLCOLBODYB9visio.lign color Body BVLCOLBODYBVLCOLBODYB2025-03-10
EBREVLCOLBODYC9visio.lign color Body CVLCOLBODYCVLCOLBODYC2025-03-10
EBREVLCOLBODYD9visio.lign color Body DVLCOLBODYDVLCOLBODYD2025-03-10
EBREVLCOLBROWN9visio.lign color BrownVLCOLBROWNVLCOLBROWN2025-03-10
EBREVLCOLCREME9visio.lign color CremeVLCOLCREMEVLCOLCREME2025-03-10
EBREVLCOLGLIGHT9visio.lign color Gum LightVLCOLGLIGHTVLCOLGLIGHT2025-03-10
EBREVLCOLGPINK9visio.lign color Gum PinkVLCOLGPINKVLCOLGPINK2025-03-10
EBREVLCOLGRED9visio.lign color Gum RedVLCOLGREDVLCOLGRED2025-03-10
EBREVLCOLGREYBL9visio.lign color Grey-BlueVLCOLGREYBLVLCOLGREYBL2025-03-10
EBREVLCOLOLIVE9visio.lign color OliveVLCOLOLIVEVLCOLOLIVE2025-03-10
EBREVLCOLORANGE9visio.lign color OrangeVLCOLORANGEVLCOLORANGE2025-03-10
EBREVLCOLROSE9visio.lign color RoseVLCOLROSEVLCOLROSE2025-03-10
EBREVLCOLSET9visio.lign color SetVLCOLSETVLCOLSET2025-03-10
EBREVLCOLSKIT9visio.lign color Starter KitVLCOLSKITVLCOLSKIT2025-03-10
EBREVLCOLWHITE9visio.lign color WhiteVLCOLWHITEVLCOLWHITE2025-03-10
EBREVLCOLYELLOW9visio.lign color YellowVLCOLYELLOWVLCOLYELLOW2025-03-10
EBREVLSHIELDHV59visio.lign shield HVVLSHIELDHV5VLSHIELDHV52025-03-10

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