HYGENIC® GuttaFlow®2 60013709

GUDID E165600137090

Coltène/Whaledent GmbH + Co. KG

Endodontic filling/sealing material
Primary Device IDE165600137090
NIH Device Record Key1e15a913-b99e-44e6-bd0e-3f4619d44306
Commercial Distribution StatusIn Commercial Distribution
Brand NameHYGENIC® GuttaFlow®2
Version Model NumberSTANDARD SET
Catalog Number60013709
Company DUNS315494443
Company NameColtène/Whaledent GmbH + Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4973458050
Emailinfo.de@coltene.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE165600137090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EKMGutta-Percha

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-12-29

On-Brand Devices [HYGENIC® GuttaFlow®2]

E165600137460REFILL PACK DUAL-BARREL SYRING
E165600137130REFILL PACK CAPSULES FAST
E165600137110REFILL PACK CAPSULES REGULAR
E165600137100The HYGENIC® GuttaFlow®2 Introkit contains 1 x Capsules GuttaFlow®2 (20 pcs), 1 x Canal Tips
E165600137090STANDARD SET

Trademark Results [HYGENIC]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HYGENIC
HYGENIC
78436768 3024860 Live/Registered
Tennant Company
2004-06-17
HYGENIC
HYGENIC
76608566 3069817 Live/Registered
HYGENIC INTANGIBLE PROPERTY HOLDING CO.
2004-08-20
HYGENIC
HYGENIC
73224163 1173854 Dead/Cancelled
Hygenic Corporation, The
1979-07-20

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