FDA.reportPublic FDA data

EVOLVE KoR

Primary DI
00818524020714
Brand
EVOLVE KoR
Company
CROWN DELTA CORPORATION
Model
10-1015A
Catalog number
10-1015A
Device description
EVOLVE KoR LIGHT BODY SHM FAST SET CARTRIDGE
Published
2023-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ELWMaterial, Impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818524020711PackageGS12In Commercial Distribution
00818524020714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081852402071110818524020711
00818524020714008185240207148185240207140818524020714

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
030479000
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818524020721PerectoDW642026-04-22
00818524020370IMPRESS-RITE T-MIXING TIPSIMP-8104TIMP-8104T2019-10-29
00818524020417IMPRESS-RITE T-MIXING TIPSIMP-8105TIMP-8105T2019-10-29
00818524020455IMPRESS-RITE T-MIXING TIPSIMP-8106TIMP-8106T2019-10-29
00818524020547IMPRESS-RITE HP MIXING TIPSVPS-8120VPS-81202019-10-07
00818524020608IMPRESS-RITE T-MIXING TIPSVPS-8108TVPS-8108T2020-02-04
00818524020660IMPRESS-RITE T-MIXING TIPSVPS8150TVPS8150T2020-12-14
00818524020691IMPRESS-RITE HP-MIXING TIPSIMP-8140IMP-81402020-12-22
00818524020080ROOT LABS - TIPSRL500RL5002017-05-01
00818524020097ROOT LABS - MIXING TIPSRL510RL5102017-05-01
00818524020158ROOT LABS - MIXING TIPSRL850RL8502017-05-01
00818524020165ROOT LABS - DISPENSERRL762RL7622017-05-01
00818524020479IMPRESS-RITE HP MIXING TIPSVPS-8105VPS-81052017-07-05
00818524020486IMPRESS-RITE HP MIXING TIPSVPS-8106VPS-81062017-07-05
00818524020493IMPRESS-RITE HP MIXING TIPSVPS-8104VPS-81042017-07-05
00818524020509IMPRESS-RITE INTRA-ORAL TIPSVPS-8103VPS-81032017-07-05
00818524020516IMPRESS-RITE INTRA-ORAL TIPSVPS-8101VPS-81012017-07-05
00818524020561IMPRESS-RITE DISPENSERVPS-8201VPS-82012017-07-05
00818524020639IMPRESS-RITEIMP-8140IMP-81402017-07-05
00818524020707IMPRESS-RITE HP-MIXING TIPSIMP-8140IMP-81402020-12-22

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