FDA.report

vks-oc 1.7 exchangeable Stud

Primary DI
EBRE450000589
Brand
vks-oc 1.7 exchangeable Stud
Company
bredent GmbH & Co. KG
Model
45000058
Catalog number
45000058
Device description
vks-oc 1.7 exchangeable Stud 5 Parts 1 Assortment
Published
2016-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EGGATTACHMENT, PRECISION, ALL

Product Code Classifications

CodeDeviceSpecialtyClass
EGGAttachment, Precision, AllDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
EBRE450000589PackageHIBCC1Not in Commercial Distribution
EBRE450000580PrimaryHIBCC0
EBRE450000588Unit of UseHIBCC0

GMDN Terms

TermDefinition
Bar dental precision attachmentA small shaft or splint typically made of austenitic alloys or alloys containing 75 percent or greater gold (Au) and metals of the platinum group, intended for use in prosthetic dentistry in conjunction with removable partial dentures. Various forms of the device are intended to connect a lower partial denture with another lower partial denture, to connect an upper partial denture with another upper partial denture, to connect either an upper or lower partial denture to a tooth or a crown, or to connect a fixed bridge to a partial denture. The device typically includes fixers (e.g., clasps, sleeves, or screws).

Sterilization Methods

Method

Contacts

PhoneEmail
+4907309872451info@bredent.com

Regulatory Flags

DUNS number
341086190
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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
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