Model: BMARPEL
DI: D775BMARPEL0
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
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:
aed425c9-8ab8-474c-be5d-b23122d7f960
Distribution Status:
In Commercial Distribution
DUNS Number:
041854332
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
No
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:
D775BMARPEL0
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 65677
Name: Orthodontic palate expander screw, bonded
Definition:
An orthodontic device intended to be used as part of a bonded palate expander to gradually spread the maxillary arch to create space for teeth alignment. It is in the form of a threaded rod with expandable pins of various lengths; it is intended to remain in the oral cavity for the duration of treatment (fixed), and may be periodically adjusted by an orthodontist to affect skeletal and/or dental changes. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.
FDA Product Codes
DYJ
Retainer, Screw Expansion, Orthodontic
PNN
Orthodontic Software