HYGENIC® Paper Points H02131

GUDID E165H021310

HYGENIC® Absorbent Paper Points ISO 45 - 80

Coltène/Whaledent GmbH + Co. KG

Endodontic paper point
Primary Device IDE165H021310
NIH Device Record Key9bf3c71c-7c05-45b0-9bf3-e2ed8cc1af4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameHYGENIC® Paper Points
Version Model NumberH02131
Catalog NumberH02131
Company DUNS315494443
Company NameColtène/Whaledent GmbH + Co. KG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com
Phone+4973458050
Emailservice@coltene.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *keep away from sunlight
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 37 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE165H021310 [Primary]

FDA Product Code

EKNPoint, Paper, Endodontic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-02-11
Device Publish Date2023-02-13

On-Brand Devices [HYGENIC® Paper Points]

E165H033510HYGENIC® Absorbent Paper Points conv. # XXF - XC
E165H033500HYGENIC® Absorbent Paper Points conv. # XC
E165H033490HYGENIC® Absorbent Paper Points conv. # C
E165H033480HYGENIC® Absorbent Paper Points conv. # M
E165H033470HYGENIC® Absorbent Paper Points conv. # F
E165H033460HYGENIC® Absorbent Paper Points conv. # XF
E165H033450HYGENIC® Absorbent Paper Points conv. # XXF
E165H032070HYGENIC® STER-I-CELL Paper Points conv. # XXF - XC
E165H032060HYGENIC® STER-I-CELL Paper Points conv. # XC
E165H032050HYGENIC® STER-I-CELL Paper Points conv. # C
E165H032040HYGENIC® STER-I-CELL Paper Points conv. # M
E165H032030HYGENIC® STER-I-CELL Paper Points conv. # F
E165H032020HYGENIC® STER-I-CELL Paper Points conv. # XF
E165H032010HYGENIC® STER-I-CELL Paper Points conv. # XXF
E165H031990HYGENIC® STER-I-CELL Paper Points Top color ISO 45 - 80
E165H031860HYGENIC® STER-I-CELL Paper Points Top color ISO 45
E165H031850HYGENIC® STER-I-CELL Paper Points Top color ISO 40
E165H031840HYGENIC® STER-I-CELL Paper Points Top color ISO 35
E165H031830HYGENIC® STER-I-CELL Paper Points Top color ISO 30
E165H031820HYGENIC® STER-I-CELL Paper Points Top color ISO 25
E165H031810HYGENIC® STER-I-CELL Paper Points Top color ISO 20
E165H031800HYGENIC® STER-I-CELL Paper Points Top color ISO 15
E165H021210HYGENIC® Absorbent Paper Points ISO 55
E165H021200HYGENIC® Absorbent Paper Points ISO 50
E165H021190HYGENIC® Absorbent Paper Points ISO 45
E165H021180HYGENIC® Absorbent Paper Points ISO 40
E165H021170HYGENIC® Absorbent Paper Points ISO 35
E165H021160HYGENIC® Absorbent Paper Points ISO 30
E165H021150HYGENIC® Absorbent Paper Points ISO 25
E165H021140HYGENIC® Absorbent Paper Points ISO 20
E165H021130HYGENIC® Absorbent Paper Points ISO 15
E165600191430HYGENIC® STER-I-CELL Paper Points Greater Taper 0.06 # 20 - 45
E165600191420HYGENIC® STER-I-CELL Paper Points Greater Taper 0.06 # 45
E165600191410HYGENIC® STER-I-CELL Paper Points Greater Taper 0.06 # 40
E165600191400HYGENIC® STER-I-CELL Paper Points Greater Taper 0.06 # 35
E165600191390HYGENIC® STER-I-CELL Paper Points Greater Taper 0.06 # 30
E165600191380HYGENIC® STER-I-CELL Paper Points Greater Taper 0.06 # 25
E165600191360HYGENIC® STER-I-CELL Paper Points Greater Taper 0.06 # 20
E165600191350HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 20 - 45
E165600191340HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 60
E165600191330HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 50
E165600191320HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 45
E165600191310HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 40
E165600191300HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 35
E165600191290HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 30
E165600191280HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 25
E165600191270HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 20
E165600191260HYGENIC® STER-I-CELL Paper Points Greater Taper 0.04 # 15
E165H076900HYGENIC® Spectra Point® Absorbent Paper Points ISO 45 - 80
E165H076890HYGENIC® Spectra Point® Absorbent Paper Points ISO 15 - 40

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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