Device
JMU Bondable Buccal Tubes, Monoblock, 2nd Molar, Roth 0.022", Single Non-Convertible, 20sets, 80pcs/box. Sold by box.
Manufacturer
JMU DENTAL, INC
Model: 38801049 DI: 00840456221709 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: Yes Rx: No OTC: No
First Published: 2026-05-11 Current Version: 2026-05-19
Description
JMU Bondable Buccal Tubes, Monoblock, 2nd Molar, Roth 0.022", Single Non-Convertible, 20sets, 80pcs/box. Sold by box.
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: cf88876d-7825-48f4-ac05-d5d049ee615b
Distribution Status: In Commercial Distribution
DUNS Number: 081258380
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: 00840456221709
Type: Primary
Issuing Agency: GS1
GMDN
Code: 31759
Name: Orthodontic tube
Definition:
A device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.
FDA Product Codes
DZD
Tube, Orthodontic