EVOLVE KoR 10-1015A

GUDID 00818524020714

EVOLVE KoR LIGHT BODY SHM FAST SET CARTRIDGE

CROWN DELTA CORPORATION

Silicone dental impression material
Primary Device ID00818524020714
NIH Device Record Keye3a259ca-6a62-4edc-86bf-9365503fd4fc
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVOLVE KoR
Version Model Number10-1015A
Catalog Number10-1015A
Company DUNS030479000
Company NameCROWN DELTA CORPORATION
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100818524020714 [Primary]
GS110818524020711 [Package]
Package: Inner Pack [2 Units]
In Commercial Distribution

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 Date2023-09-29
Device Publish Date2023-09-21

Devices Manufactured by CROWN DELTA CORPORATION

00818524020714 - EVOLVE KoR2023-09-29EVOLVE KoR LIGHT BODY SHM FAST SET CARTRIDGE
00818524020714 - EVOLVE KoR2023-09-29 EVOLVE KoR LIGHT BODY SHM FAST SET CARTRIDGE
00818524020707 - IMPRESS-RITE HP-MIXING TIPS2020-12-30 M&S DENTAL IMPRESS-RITE HP TEMPORARY CEMENT MIXING TIP
00818524020684 - IMPRESS-RITE T-MIXING TIPS2020-12-22 M&S DENTAL CORE MATERIAL T-MIXER BROWN 1:1 BLUNT END 20 PER BAG
00818524020646 - IMPRESS-RITE 3802020-02-24 M&S DENTAL IMPRESS-RITE 380 MONOPHASE REGULAR SET STARTER KIT
10818524020629 - IMPRESS-RITE2020-02-18 M&S DENTAL IMPRESS-RITE 380 HEAVY BODY REGULAR SET
10818524020605 - IMPRESS-RITE T-MIXING TIPS2020-02-12 M&S DENTAL IMPRESS-RITE T-MIXERS C&B BLUE ORANGE 25 PER BAG
00818524020523 - IMPRESS-RITE HP MIXING TIPS2020-02-06 M&S DENTAL IMPRESS-RITE C&B BLUE ORANGE 25 PER BAG
10818524020377 - IMPRESS-RITE T-MIXING TIPS2019-11-06 M&S DENTAL IMPRESS-RITE GREEN T-MIXERS (6.5MM) 48/BAG

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