FDA.reportPublic FDA data

HyFlex™ Guttapercha Points

Primary DI
E165600227100
Brand
HyFlex™ Guttapercha Points
Company
Coltène/Whaledent GmbH + Co. KG
Model
60022710
Catalog number
60022710
Device description
HyFlex™ EDM Guttapercha Points 0.02 # 60
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
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKMGutta-Percha

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E165600227101PrimaryHIBCC0
E165600227100Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Root canal obturating pointA metallic or polymeric based point or cone suitable for use in the obturation of the dental root-canal, but not for support of a coronal restoration.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep away from sunlight
Special Storage Condition, Specify00keep dry
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4973458050info.de@coltene.com
+4973458050service@coltene.com

Regulatory Flags#

DUNS number
315494443
Device count
60
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
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 DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06978880221348ZarcShanghai Xing Yu Medical Equipment Co.,Ltd.EKM2026-03-09
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