Device
068990MU35+1 1st Molar Bnd RU35+ P/W 068-990 & 485-006
Manufacturer
3M UNITEK CORPORATION
3M UNITEK CORPORATION
Model: 068990MU35+1
Catalog: 068990MU35+1
DI: 00652221212818
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
068990MU35+1 1st Molar Bnd RU35+ P/W 068-990 & 485-006
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
56dca03a-b360-49db-9ad1-e6fb8bf280b1
Distribution Status:
In Commercial Distribution
DUNS Number:
008256356
Device Count:
5
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
Item #1 - Device ID:
80652221212814
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00652221212818
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 38734
Name: Orthodontic metal band
Definition:
A thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.
FDA Product Codes
ECM
BAND, PREFORMED, ORTHODONTIC