KöR 10-1008

GUDID 00850362007021

KöR Impression Tray Adhesive is an adhesive developed specifically for durable adhesion of addition curing vinyl silicone impression materials to disposable impression trays and avoids lifting of the impression material from the tray when taking the impression out of the mouth.

EVOLVE DENTAL TECHNOLOGIES, INC.

Dental impression adhesive
Primary Device ID00850362007021
NIH Device Record Key6f9047b5-723a-4bc0-b3a4-50edc0fc360b
Commercial Distribution StatusIn Commercial Distribution
Brand NameKöR
Version Model NumberKöR Impression Tray Adhesive
Catalog Number10-1008
Company DUNS005479970
Company NameEVOLVE DENTAL TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Phone949 713-0909
Emaillfjastad@evolvedental.com
Phone949 713-0909
Emaillfjastad@evolvedental.com
Phone949 713-0909
Emaillfjastad@evolvedental.com
Phone949 713-0909
Emaillfjastad@evolvedental.com
Phone949 713-0909
Emaillfjastad@evolvedental.com
Phone949 713-0909
Emaillfjastad@evolvedental.com
Phone949 713-0909
Emaillfjastad@evolvedental.com
Phone949 713-0909
Emaillfjastad@evolvedental.com
Phone949 713-0909
Emaillfjastad@evolvedental.com
Phone949 713-0909
Emaillfjastad@evolvedental.com
Phone949 713-0909
Emaillfjastad@evolvedental.com
Phone949 713-0909
Emaillfjastad@evolvedental.com
Phone949 713-0909
Emaillfjastad@evolvedental.com
Phone949 713-0909
Emaillfjastad@evolvedental.com
Phone949 713-0909
Emaillfjastad@evolvedental.com

Device Dimensions

Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter
Total Volume10 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100850362007021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-25
Device Publish Date2019-03-15

On-Brand Devices [KöR]

00850362007106Tooth desensitizer for reduction or elimination of teeth sensitivity during teeth whitening and
00850362007090Tooth desensitizer for reduction or elimination of teeth sensitivity during teeth whitening and
00850362007083Tooth desensitizer for reduction or elimination of teeth sensitivity during teeth whitening and
00850362007076KöR Teeth Desensitizer - 5ml
00850362007069KöR Teeth Desensitizer - 2.5ml
00850362007052KöR Desensitizer-10ml
00850362007045Impression Material - Super-Hydrophilic Vinyl Polysiloxane, Fast Set
00850362007038Impression Material - Super-Hydrophilic Vinyl Polysiloxane Light Body Wash
00850362007021KöR Impression Tray Adhesive is an adhesive developed specifically for durable adhesion of addi
00850362007014Vinyl Polysiloxane Putty - Regular set impression material.
00850362007007Vinyl Polysiloxane Putty - Fast set impression material.
00850362007175Dental cheek retractor.
00850362007168Dental cheek retractor.
00850362007151Dental cheek retractor.
00850362007144Dental Suction Tip
00850362007120Dental retractor and suction tip.
00850362007113Dental cheek retractor and suction tip.
00850362007137Dental dam.

Trademark Results [KöR]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KOR
KOR
97737250 not registered Live/Pending
AGAOGLU HAVACILIK VE SAVUNMA SANAYI LIMITED SIRKETI
2022-12-30
KOR
KOR
97682482 not registered Live/Pending
Bear Hyde, LLC
2022-11-17
KOR
KOR
97042512 not registered Live/Pending
Bear Hyde, LLC
2021-09-23
KOR
KOR
90270041 not registered Live/Pending
Econotone USA Inc.
2020-10-21
KOR
KOR
88840263 not registered Live/Pending
Rheem Manufacturing Company
2020-03-19
KOR
KOR
88811904 not registered Live/Pending
KOR Water, Inc.
2020-02-26
KOR
KOR
88811865 not registered Live/Pending
KOR Water, Inc.
2020-02-26
KOR
KOR
88762736 not registered Live/Pending
Kite Pharma, Inc.
2020-01-16
KOR
KOR
88469981 not registered Live/Pending
Kennametal Inc.
2019-06-12
KOR
KOR
88345247 not registered Live/Pending
KOR International Ltd.
2019-03-18
KOR
KOR
88345242 not registered Dead/Abandoned
KOR International Ltd.
2019-03-18
KOR
KOR
87877392 not registered Live/Pending
KOR SHOTS INC.
2018-04-14

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