FDA.reportPublic FDA data

3M™

Primary DI
04035077200004
Brand
3M™
Company
3M Deutschland GmbH
Model
12012012
Catalog number
12012012
Device description
3M™ Filtek Composite Warmer
Published
2024-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QGOComposite resin warmer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QGOComposite Resin WarmerDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04035077200004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04035077200004040350772000044035077200004

GMDN Terms#

Term, Definition table
TermDefinition
Dental material heaterAn electrically-powered device designed to be used to heat, through conduction, a variety of materials/substances (e.g., composite resin, root canal cleaning solution, local anaesthetic agent) to facilitate application of the material (e.g., optimum performance, patient comfort) during a dental procedure. It consists of a heating element with a temperature controller and a heater plate.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)634-22493Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
315731711
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
307073877737323M™ Coban™2094N2094N2026-05-08
307073877737493M™ Coban™2794N2794N2026-05-08
340467190223813M™ Coban™209420942026-05-08
507073878180243M™ Tegaderm™1624WNS1624WNS2026-05-08
507073878180313M™ Tegaderm™1626WNS1626WNS2026-05-08
507073878180483M™ Tegaderm™1628NS1628NS2026-05-08
507073878180553M™ Tegaderm™1688NS1688NS2026-05-08
507073878180623M™ Tegaderm™1685NS1685NS2026-05-08
507073878180793M™ Tegaderm™1683NS1683NS2026-05-08
007073874969683M™CMW06CMW062026-05-08
007073874969753M™CMW04CMW042026-05-08
007073874969823M™CMW03CMW032026-05-08
007073874969993M™CMW02CMW022026-05-08
007073878101223M™ Micropore™1530SS-11530SS-12026-05-08
040467192917003M™ Coban™2794E2794E2026-05-08
040545960049553M™ Coban™209220922026-05-08
040545966458133M™71507715072026-05-08
040545967341423M™ Penta™77944779442026-05-08
040545967342273M™ Penta™76994769942026-05-08
040545967359103M™ Impregum™P31779P317792026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D8691300001AdDentADDENT, INC.QGO2026-04-22
00197998102578Solventum™ Filtek™Solventum Germany GmbHQGO2025-11-03
00197998102608Solventum™ Filtek™Solventum Germany GmbHQGO2025-11-03
00197998102615Solventum™ Filtek™Solventum Germany GmbHQGO2025-11-03
00197998327667Solventum™ Filtek™Solventum Germany GmbHQGO2025-04-03
10818207022162Phasor KitVista DentalQGO2022-09-01
10818207023107Vista 240V 6cc Syringe WarmerVista DentalQGO2022-09-01
10818207023114Vista 220V 12cc Syringe WarmerVista DentalQGO2022-09-01
10818207023121Vista 120V 6cc Syringe WarmerVista DentalQGO2022-09-01
10818207023138Vista 120V 12cc Syringe WarmersVista DentalQGO2022-09-01
10818207022155Phasor NoseconesVista DentalQGO2022-09-01
00818207022165Phasor KitVista DentalQGO2022-09-01
00818207023100Vista 240V 6cc Syringe WarmerVista DentalQGO2022-09-01
00818207023117Vista 220V 12cc Syringe WarmerVista DentalQGO2022-09-01
00818207023124Vista 120V 6cc Syringe WarmerVista DentalQGO2022-09-01
00818207023131Vista 120V 12cc Syringe WarmersVista DentalQGO2022-09-01
E22191461VisCalor DispenserVOCO GmbHQGO2019-11-26
E22199951VisCalor DispenserVOCO GmbHQGO2019-11-26
E22191431VisCalor DispenserVOCO GmbHQGO2019-05-10
E22191441VisCalor DispenserVOCO GmbHQGO2019-05-10
E22191451VisCalor DispenserVOCO GmbHQGO2019-05-10