Model: AHBC
DI: D775AHBC0
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-10
Current Version: 2026-05-18
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7a83b54f-cc11-4e8d-b07a-10c9f366f824
Distribution Status:
In Commercial Distribution
DUNS Number:
041854332
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
D775AHBC0
Type:
Primary
Issuing Agency:
HIBCC
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