Device
3M™ Filtek™ One Bulk Fill Restorative, 4866A1, 1 - 4g Syringe
Manufacturer
3M COMPANY
Model: 4866A1 Catalog: 4866A1 DI: 10605861077436 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-05-08 Current Version: 2026-05-18
Description
3M™ Filtek™ One Bulk Fill Restorative, 4866A1, 1 - 4g Syringe
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: cb1d031a-a0a1-4ace-91c6-db539cecd94f
Distribution Status: In Commercial Distribution
DUNS Number: 830016148
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
Item #1 - Pkg Type: CASE
Item #1 - Device ID: 50605861077434
Item #1 - Pkg Status: In Commercial Distribution
Item #1 - Pkg Quantity: 10
Item #1 - Device ID Type: Package
Item #1 - Contains DINumber: 10605861077436
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 10605861077436
Item #2 - Device ID Type: Primary
Item #2 - 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