Home GUDID 00197998216176 Clarity™
Primary DI 00197998216176
Brand Clarity™
Company Solventum Orthodontics Corporation
Model 355-205
Catalog number 355-205
Device description Clarity™ Digital Bonding Tray , Dual Arch Lost/Damaged
Published 2026-04-25
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name EBH MATERIAL, IMPRESSION TRAY, RESIN
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EBH Material, Impression Tray, Resin Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00197998216176 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 00197998216176 00197998216176 197998216176 0197998216176
GMDN Terms# Term, Definition table Term Definition Orthodontic appliance/positioning tray kit A collection of dental devices which includes a custom-made positioning tray (indirect bonding tray) intended to position and hold in place a set of included orthodontic appliances (e.g., brackets, buccal tubes, lingual retainers) to bond them to teeth during a single procedure. The components are typically made of synthetic polymer and/or metal materials and include appliances manufactured from an oral cavity impression or oral scan for a specific patient (custom-made). This is a single-use device.
Regulatory Flags# DUNS number 119329099 Device count 1 DM exempt true Premarket exempt true Lot or batch true Manufacturing date on label 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 D080XXTRR05KGXXW050 TrinDy Try-In YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRR05KGXXXA10 TrinDy Try-In YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRR05KGXXXA20 TrinDy Try-In YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRRX1KGXXW050 TrinDy Try-In YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRRX1KGXXXA10 TrinDy Try-In YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRRX1KGXXXA20 TrinDy Try-In YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRT05KGXXBLU0 TrinDy Tray YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRT05KGXXPNK0 TrinDy Tray YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRTX1KGXXBLU0 TrinDy Tray YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 D080XXTRTX1KGXXPNK0 TrinDy Tray YAMAHACHI DENTAL MFG.,CO. EBH 2026-04-27 00197998216121 Clarity™ Solventum Orthodontics Corporation EBH 2026-04-25 00197998216138 Clarity™ Solventum Orthodontics Corporation EBH 2026-04-25 00197998216152 Clarity™ Solventum Orthodontics Corporation EBH 2026-04-25 00197998216169 Clarity™ Solventum Orthodontics Corporation EBH 2026-04-25 09359215000376 DentaTRAY Orange ASIGA PTY LTD EBH 2025-01-17 08800017902043 Disposable Impression Bite Tray DXM CO., LTD EBH 2024-06-11 08800017902074 Disposable Impression Bite Tray DXM CO., LTD EBH 2024-06-11 D248628000 Surfactant 32oz HAGER WORLDWIDE, INC. EBH 2023-07-13 D248628011 Surfactant 8oz HAGER WORLDWIDE, INC. EBH 2023-07-13 20386040012710 COE® Gc America Inc. EBH 2023-04-20 20386040012727 COE® Gc America Inc. EBH 2023-04-20 20386040012734 COE® Gc America Inc. EBH 2023-04-20 20386040012741 COE® Gc America Inc. EBH 2023-04-20 20386040012758 COE® Gc America Inc. EBH 2023-04-20 20386040012765 COE® Gc America Inc. EBH 2023-04-20 20386040012772 COE® Gc America Inc. EBH 2023-04-20 20386040012789 COE® Gc America Inc. EBH 2023-04-20 20386040012796 COE® Gc America Inc. EBH 2023-04-20 40386040001886 COE® Gc America Inc. EBH 2023-04-20 40386040001893 COE® Gc America Inc. EBH 2023-04-20
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