FDA.reportPublic FDA data

KöR

Primary DI
00850362007014
Brand
KöR
Company
EVOLVE DENTAL TECHNOLOGIES, INC.
Model
KöR Putty - Regular Set
Catalog number
10-1014
Device description
Vinyl Polysiloxane Putty - Regular set impression material.
Published
2017-03-10
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
K821221000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K821221000DENTAL IMPRESSION MATERIALCrown Delta Corp.1982-06-07ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850362007014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850362007014008503620070148503620070140850362007014

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Maximum Storage Temperature 73°F (23°C)

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9497130909lfjastad@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
00850362007021KöRKöR Impression Tray Adhesive10-10082019-03-15
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
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
08056640080997Ormadent PuttyMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081093OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081109OrmactivatorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081161OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081185OrmamaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081598Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081604Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081611Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081642Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081666Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081673Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081734Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081741Ormaplus labMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081802Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081819Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081826Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081833Ormalab 75MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081925Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640081994Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082007Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082014Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082038Ormalab 95MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082601Ormalab 85MAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640082991AlginmajorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083042AlginmajorMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083080AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083134AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083141AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083196AlginmaxMAJOR PRODOTTI DENTARI SPAELW2026-10-20
08056640083202AlginkidMAJOR PRODOTTI DENTARI SPAELW2026-10-20