Device
Clarity Aligners-Retainer, Dual Arch
Manufacturer
Solventum Orthodontics Corporation
Solventum Orthodontics Corporation
Model: 359-460
Catalog: 359-460
DI: 00197998216633
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 Aligners-Retainer, Dual Arch
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
dcf350ab-0434-4248-9c53-b4098740a86f
Distribution Status:
In Commercial Distribution
DUNS Number:
119329099
Device Count:
1
DM Exempt:
No
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:
00197998216633
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35310
Name: Orthodontic retainer
Definition:
An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.
FDA Product Codes
DYJ
RETAINER, SCREW EXPANSION, ORTHODONTIC