Device
4006-141 APC FF Clarity ADVANCED Hi TQ U/L Lt/Rt 5X5 Hk 018
Manufacturer
3M UNITEK CORPORATION
3M UNITEK CORPORATION
Model: 4006-141
Catalog: 4006-141
DI: 00652221228000
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-25
Current Version: 2026-05-04
Description
4006-141 APC FF Clarity ADVANCED Hi TQ U/L Lt/Rt 5X5 Hk 018
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c66dd321-f625-46d6-a485-e02232d7ac6b
Distribution Status:
In Commercial Distribution
DUNS Number:
008256356
Device Count:
20
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:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Device ID:
80652221228006
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00652221228000
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
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