Device
3M™ Filtek™ One Bulk Fill Restorative Sample, 4867A3-S, 5 - 0.2g Capsules
Manufacturer
3M COMPANY
3M COMPANY
Model: 4867A3-S
Catalog: 4867A3-S
DI: 10605861077665
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
3M™ Filtek™ One Bulk Fill Restorative Sample, 4867A3-S, 5 - 0.2g Capsules
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
f4bee0fa-4219-40c3-8d25-816e854e456c
Distribution Status:
In Commercial Distribution
DUNS Number:
830016148
Device Count:
5
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
Item #1 - Pkg Type:
CASE
Item #1 - Device ID:
50605861077663
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10605861077665
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10605861077665
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
00605861077668
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 35870
Name: Dental composite resin
Definition:
A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.
FDA Product Codes
EBF
Material, tooth shade, resin