Home GUDID 00850017524064 BrightByte
Primary DI 00850017524064
Brand BrightByte
Company STRAIGHT SMILE LLC
Model bb
Device description A liquid cleansing agent used to remove small debris from plastic aligners
Published 2022-09-30
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name EFT Cleanser, Denture, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EFT Cleanser, Denture, Over The Counter Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00850017524064 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00850017524064 00850017524064 850017524064 0850017524064
GMDN Terms# Term, Definition table Term Definition Denture cleanser An agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.
Regulatory Flags# DUNS number 081010579 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810051088649 GuruNanda Aligner and Denture Cleaning Foam Gurunanda, LLC EFT 2026-04-29 00810194403972 Aira AIRA, LLC EFT 2026-01-16 10810194403979 Aira AIRA, LLC EFT 2026-01-16 00850078989307 SmileSet Universal Cleaning Tablets – 90 pc Ortho Dental Lab LLC EFT 2025-09-25 00850078989314 SmileSet Universal Cleaning Tablets - Sample 6pc Ortho Dental Lab LLC EFT 2025-09-17 00616784487724 WeCare Denture Cleanser, Antibacterial Dynarex Corporation EFT 2025-09-01 00810180842273 WeCare Denture Cleanser, Antibacterial Dynarex Corporation EFT 2025-09-01 00855850008061 Smilesaver Soluria II LLC EFT 2024-06-19 00855850008078 Smilesaver Soluria II LLC EFT 2024-06-19 00855850008092 Guard Health Soluria II LLC EFT 2024-06-19 00855850008108 Smilesaver Soluria II LLC EFT 2024-06-19 00364031300165 SECURE Cleansing Tablets FITTYDENT INTERNATIONAL GmbH EFT 2023-10-02 D832200451 Plasdent PLASDENT CORPORATION EFT 2023-05-31 D832200450 Plasdent PLASDENT CORPORATION EFT 2023-05-31 00665973010878 DawnMist Dukal LLC EFT 2022-12-06 00665973010885 DawnMist Dukal LLC EFT 2022-12-06 D784UZM30011 Unipack UNIPACK MEDICAL CORPORATION EFT 2022-12-06 06943566100118 Y-Kelin ANHUI GREENLAND BIOTECH CO.,LTD EFT 2022-12-06 06943566107391 Y-Kelin ANHUI GREENLAND BIOTECH CO.,LTD EFT 2022-12-06 20665973010872 DawnMist Dukal LLC EFT 2022-12-06 20665973010889 DawnMist Dukal LLC EFT 2022-12-06 00816063021407 Cleaning Crystals, Packette Align Technology, Inc. EFT 2022-12-06 16943566100115 Y-Kelin ANHUI GREENLAND BIOTECH CO.,LTD EFT 2022-12-06 16943566107398 Y-Kelin ANHUI GREENLAND BIOTECH CO.,LTD EFT 2022-12-06 D784UZM30015 Unipack UNIPACK MEDICAL CORPORATION EFT 2022-12-06 00814832015879 EFFERDENT ORIGINAL 102CT TAB 6 Medtech Products Inc. EFT 2022-11-17 00814832015923 EFFERDENT PM 90CT TAB 6 Medtech Products Inc. EFT 2022-11-17 10814832015876 EFFERDENT ORIGINAL 102CT TAB 6 MEDTECH PRODUCTS INC. EFT 2022-11-17 10814832015920 EFFERDENT PM 90CT TAB 6 MEDTECH PRODUCTS INC. EFT 2022-11-17 00814832015862 EFFDNT ORIG 44CT TAB 6 Medtech Products Inc. EFT 2022-11-16