FDA.report

HyFlex™ Guttapercha Points

Primary DI
E165600227010
Brand
HyFlex™ Guttapercha Points
Company
Coltène/Whaledent GmbH + Co. KG
Model
60022701
Catalog number
60022701
Device description
HyFlex™ CM Guttapercha Points 0.06 # 40
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

Related Records

Contact Domains

Product Codes

CodeName
EKMGutta-Percha

Product Code Classifications

CodeDeviceSpecialtyClass
EKMGutta-PerchaDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E165600227011PrimaryHIBCC0
E165600227010Unit of UseHIBCC0

GMDN Terms

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

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

Contacts

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

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E165H076840HYGENIC® Paper PointsH07684H076842023-02-13
E165H076850HYGENIC® Paper PointsH07685H076852023-02-13

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