Model: CL-D-131515
DI: 04719896291381
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-19
Current Version: 2026-05-27
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
6e447137-e7d2-4d69-86b1-e1a6093a5fe3
Distribution Status:
In Commercial Distribution
DUNS Number:
656214227
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04719896291381
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 31797
Name: Orthodontic spring
Definition:
A dental device in the shape of a coil intended to be placed around an archwire, a rod, in a bracket, on hooks, pins, and/or between teeth, to apply force (e.g., rotational, uprighting, horizontal) as part of an orthodontic force-producing appliance system. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.
FDA Product Codes
ECO
Spring, Orthodontic