Home GUDID D772ATI1400030 JUSTI DENTURE
Primary DI D772ATI1400030
Brand JUSTI DENTURE
Company AMERICAN TOOTH INDUSTRIES
Model 072-14-0003
Device description JUSTI DENTURE RELINER KIT VERY SOFT
Published 2023-10-18
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name EMA Cement, Dental
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EMA Cement, Dental Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D772ATI1400030 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Denture reliner, soft, home-use A denture relining material such as plastic resin intended to be self-applied at home as a permanent coating or lining on the base or tissue-contact surface of a denture for improved fitting, and which sets to a soft, plastic state. It will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.
Regulatory Flags# DUNS number 161532999 Device count 1 DM exempt true Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00815967029472 Rodin Pac-Dent, Inc. EMA 2026-03-23 00815967029656 Rodin Pac-Dent, Inc. EMA 2026-03-23 00815967029663 Rodin Pac-Dent, Inc. EMA 2026-03-23 00815967029670 Rodin Pac-Dent, Inc. EMA 2026-03-23 00815967029687 Rodin Pac-Dent, Inc. EMA 2026-03-23 00815967029694 Rodin Pac-Dent, Inc. EMA 2026-03-23 00815967029700 Rodin Pac-Dent, Inc. EMA 2026-03-23 00815967029717 Rodin Pac-Dent, Inc. EMA 2026-03-23 00815967029724 Rodin Pac-Dent, Inc. EMA 2026-03-23 07290115050400 High-Q-Bond SE B.J.M. LABORATORIES LTD EMA 2026-03-20 00817169021438 UPTEMP By 3D DENTAL 3D DENTAL DESIGNS AND DEVELOPMENT, LLC EMA 2026-03-05 00817169021445 UPTEMP By 3D DENTAL 3D DENTAL DESIGNS AND DEVELOPMENT, LLC EMA 2026-03-05 00840479201566 GLASSLOK RELIANCE ORTHODONTIC PRODUCTS INC EMA 2026-03-05 00840479201573 GLASSLOK RELIANCE ORTHODONTIC PRODUCTS INC EMA 2026-03-05 00840479201580 GLASSLOK RELIANCE ORTHODONTIC PRODUCTS INC EMA 2026-03-05 00840479201597 GLASSLOK RELIANCE ORTHODONTIC PRODUCTS INC EMA 2026-03-05 00840479201603 GLASSLOK RELIANCE ORTHODONTIC PRODUCTS INC EMA 2026-03-05 09336472005450 RIVA CEM AUTOMIX SDI LIMITED EMA 2026-02-16 09336472020965 RIVA CEM AUTOMIX SDI LIMITED EMA 2026-02-16 09336472032203 RIVA CEM SDI LIMITED EMA 2026-02-16 04560227803397 iCEM Universal Plus SUN MEDICAL CO.,LTD. EMA 2026-02-09 04560227803403 iCEM Universal Plus SUN MEDICAL CO.,LTD. EMA 2026-02-09 04560227803410 iCEM Universal Plus SUN MEDICAL CO.,LTD. EMA 2026-02-09 04560227803427 iCEM Universal Plus SUN MEDICAL CO.,LTD. EMA 2026-02-09 04560227803434 iCEM Universal Plus SUN MEDICAL CO.,LTD. EMA 2026-02-09 04560227803441 iCEM Universal Plus SUN MEDICAL CO.,LTD. EMA 2026-02-09 04560227803458 iCEM Universal Plus SUN MEDICAL CO.,LTD. EMA 2026-02-09 04560227803465 iCEM Universal Plus SUN MEDICAL CO.,LTD. EMA 2026-02-09 04560227803472 iCEM Universal Plus SUN MEDICAL CO.,LTD. EMA 2026-02-09 04560227803557 iCEM Universal Plus SUN MEDICAL CO.,LTD. EMA 2026-02-09