FDA.report

HyFlex™ Paper Points

Primary DI
E165600226830
Brand
HyFlex™ Paper Points
Company
Coltène/Whaledent GmbH + Co. KG
Model
60022683
Catalog number
60022683
Device description
HyFlex™ CM Paper Points 0.06 # 25
Published
2022-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EKNPoint, Paper, Endodontic

Product Code Classifications

CodeDeviceSpecialtyClass
EKNPoint, Paper, EndodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E165600226831PrimaryHIBCC0
E165600226830Unit of UseHIBCC0

GMDN Terms

TermDefinition
Endodontic paper pointA non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00keep away from sunlight
Special Storage Condition, Specify00keep dry
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature37 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
+4973458050info.de@coltene.com
+4973458050service@coltene.com

Regulatory Flags

DUNS number
315494443
Device count
100
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
true
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
E165H021220HYGENIC® Paper PointsH03180H031802023-02-13
E165H021230HYGENIC® Paper PointsH02123H021232023-02-13
E165H021240HYGENIC® Paper PointsH02124H021242023-02-13
E165H021300HYGENIC® Paper PointsH02130H021302023-02-13
E165H021310HYGENIC® Paper PointsH02131H021312023-02-13
E165H031870HYGENIC® Paper PointsH03187H031872023-02-13
E165H031880HYGENIC® Paper PointsH03188H031882023-02-13
E165H031890HYGENIC® Paper PointsH03189H031892023-02-13
E165H031900HYGENIC® Paper PointsH03190H031902023-02-13
E165H031910HYGENIC® Paper PointsH03191H031912023-02-13
E165H031980HYGENIC® Paper PointsH03198H031982023-02-13
E165H076770HYGENIC® Paper PointsH07677H076772023-02-13
E165H076780HYGENIC® Paper PointsH07678H076782023-02-13
E165H076790HYGENIC® Paper PointsH07679H076792023-02-13
E165H076800HYGENIC® Paper PointsH07680H076802023-02-13
E165H076810HYGENIC® Paper PointsH07681H076812023-02-13
E165H076820HYGENIC® Paper PointsH07682H076822023-02-13
E165H076830HYGENIC® Paper PointsH07683H076832023-02-13
E165H076840HYGENIC® Paper PointsH07684H076842023-02-13
E165H076850HYGENIC® Paper PointsH07685H076852023-02-13

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06978880220266ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKN2026-03-09
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