Device
3M Photac™ Fil Quick Aplicap™ Light-Cured Glass Ionomer Restorative,61040, NP B3
Manufacturer
3M Deutschland GmbH
Model: 61040 Catalog: 61040 DI: 04054596900776 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 Photac™ Fil Quick Aplicap™ Light-Cured Glass Ionomer Restorative,61040, NP B3
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 362a5cbf-7db1-4392-85c6-072c4fdaf0f0
Distribution Status: In Commercial Distribution
DUNS Number: 315731711
Device Count: 50
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 - Device ID: 04035077210881
Item #1 - Device ID Type: Unit of Use
Item #1 - Device ID Issuing Agency: GS1
Item #2 - Device ID: 04054596900776
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
EMA
CEMENT, DENTAL