Model: 300-M8-
DI: D841300M8221
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
ORTHODONTIC CERAMIC BRACKET
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
21c65487-4f70-4bc5-ac4f-9dbd69c0785e
Distribution Status:
In Commercial Distribution
DUNS Number:
006335558
Device Count:
1
DM Exempt:
No
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
D841300M8221
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 58937
Name: Orthodontic bracket, ceramic
Definition:
A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.
FDA Product Codes
NJM
Bracket, Ceramic, Orthodontic