Device
3M™ Filtek™ Universal Restorative Sample, 6555A3-S, 1 - 1g Syringe
Manufacturer
3M COMPANY
3M COMPANY
Model: 6555A3-S
Catalog: 6555A3-S
DI: 10605861076064
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™ Universal Restorative Sample, 6555A3-S, 1 - 1g Syringe
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
41ec3f2a-e9a9-4050-8c8a-d75869633d49
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
Device ID:
10605861076064
Type:
Primary
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