Device
Clarity™ Digital Bonding, Dual Arch Replacement
Manufacturer
Solventum Orthodontics Corporation
Solventum Orthodontics Corporation
Model: 355-203
Catalog: 355-203
DI: 00197998216152
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-25
Current Version: 2026-05-04
Description
Clarity™ Digital Bonding, Dual Arch Replacement
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
70d2214a-8416-4fa7-8f2c-a9d2e76698a3
Distribution Status:
In Commercial Distribution
DUNS Number:
119329099
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00197998216152
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64010
Name: Orthodontic appliance/positioning tray kit
Definition:
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.
FDA Product Codes
EBH
MATERIAL, IMPRESSION TRAY, RESIN