Home GUDID D757U2021P0 One Step Plus U/Dose in Pouch
Primary DI D757U2021P0
Brand One Step Plus U/Dose in Pouch
Company BISCO INC.
Model U-2021P
Catalog number U-2021P
Published 2017-06-12
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 D757U2021P0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dentine bonding agent/set A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 20 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 053529939 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false 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
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