FDA.reportPublic FDA data

KöR

Primary DI
00850362007021
Brand
KöR
Company
EVOLVE DENTAL TECHNOLOGIES, INC.
Model
KöR Impression Tray Adhesive
Catalog number
10-1008
Device description
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.
Published
2019-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992001000TRAY-LINKSilicon-Und Composite Spezialitaten GmbH1999-11-02ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850362007021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850362007021008503620070218503620070210850362007021

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression adhesiveA liquid material specifically made to give adhesion of an impression material to the impression tray. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume10Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit73 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949 713-0909lfjastad@evolvedental.com

Regulatory Flags#

DUNS number
005479970
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850362007137KöRKöR Dam80-10322021-05-18
00850362007113KöRKöR Retractor & Suction Tip (Max)80-10062021-03-31
00850362007120KöRKöR Retractor & Suction Tip (Ulra)80-10132021-03-31
00850362007144KöRKöR Suction Tip80-10292021-03-31
00850362007151KöRKöR Retractor (Blue) - Medium80-10592021-03-31
00850362007168KöRKöR Retractor (Green) - Small80-10602021-03-31
00850362007175KöRKöR Retractor (Red) - Large80-10612021-03-31
00850362007052KöRKöR Desensitizer-10ml10-10102017-01-23
00850362007069KöRKöR Teeth Desensitizer - 2.5ml10-10112017-01-23
00850362007076KöRKöR Teeth Desensitizer - 5ml10-10122017-01-23
00850362007083KöRKöR Complete Desensitizer - 5mL10-10172017-03-06
00850362007090KöRKöR Complete Desensitizer - 3mL10-10162017-03-06
00850362007106KöRKöR Complete Desensitizer - 10mL10-10182017-03-06
00850362007007KöRKöR Putty - Fast Set10-10132017-03-10
00850362007014KöRKöR Putty - Regular Set10-10142017-03-10
00850362007038KöRKöR Light Body Wash10-10152017-03-10
00850362007045KöRKöR Heavy Body Base10-10042017-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800024201986Implant Heavy BodySherpakoreaELW2023-08-03
08800024201948Precisil BigSherpakoreaELW2021-06-14
08800024201931Delikit Premium Light BodySherpakoreaELW2021-01-27
08800024201924Precisil Heavy Body FSSherpakoreaELW2021-01-25
08800024201900Delikit Light BodySherpakoreaELW2021-01-07
08800024201917Delikit Light Body FSSherpakoreaELW2021-01-07
08800024201887Delikit Heavy Body FSSherpakoreaELW2021-01-04
08800024201894Delikit Bite RegistrationSherpakoreaELW2021-01-04
08800024201870Delikit Medium BodySherpakoreaELW2020-12-21
08800024201863Deli-Bite ClearSherpakoreaELW2020-10-13
08800024201849Imflex Light BodySherpakoreaELW2020-09-18
08800024201856Imflex Putty RSSherpakoreaELW2020-09-18
08800024201825Jackpot LB FastSherpakoreaELW2020-07-23
08800024201832Jackpot LB FastSherpakoreaELW2020-07-23
08800024201795Delikit Putty RSSherpakoreaELW2020-05-12
08800024201801Delikit Putty FSSherpakoreaELW2020-05-12
08800024201696Delikit Light BodySherpakoreaELW2020-04-29
08800024201702Delikit Light BodySherpakoreaELW2020-04-29
08800024201719Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201726Delikit Light Body FSSherpakoreaELW2020-04-29
08800024201733Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201740Delikit Plant Heavy BodySherpakoreaELW2020-04-29
08800024201757Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201764Delikit Plant Light BodySherpakoreaELW2020-04-29
08800024201771Delikit Extra Light BodySherpakoreaELW2020-04-29
08800024201788Delikit Jumbo MonophaseSherpakoreaELW2020-04-29
08800024201665Delikit Heavy BodySherpakoreaELW2020-04-27
08800024201672Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201689Delikit Heavy Body FSSherpakoreaELW2020-04-27
08800024201580Imflex Heavy BodySherpakoreaELW2020-04-08