FDA.reportPublic FDA data

Solventum™ Filtek™

Primary DI
00197998327667
Brand
Solventum™ Filtek™
Company
Solventum Germany GmbH
Model
12012014
Catalog number
12012014
Device description
Solventum™ Filtek™ Composite Warmer Kit, 100-240V NA
Published
2025-04-03
Public version status
Update
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
00197998327667PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998327667001979983276671979983276670197998327667

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)634-2249regulatoryrequests@solventum.com
+1(800)228-3957regulatoryrequests@solventum.com

Regulatory Flags#

DUNS number
315518329
Device count
1
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
00197998115707Solventum™ Clinpro™67008670082026-10-09
00197998079917Solventum™ Durelon™38236382362026-10-08
00197998079955Solventum™ Durelon™38237382372026-10-08
00197998079962Solventum™ Durelon™38019380192026-10-08
00197998079986Solventum™ Durelon™38216382162026-10-08
00197998079993Solventum™ Durelon™38234382342026-10-08
00197998080005Solventum™ Durelon™38235382352026-10-08
00197998099984Solventum™ RelyX™56660566602026-10-08
00197998226724Solventum™ Protemp™46962469622026-10-08
00197998226731Solventum™ Protemp™46973469732026-10-08
00197998226748Solventum™ Protemp™46964469642026-10-08
00197998226755Solventum™ Protemp™46963469632026-10-08
00197998226762Solventum™ Protemp™46961469612026-10-08
00197998226779Solventum™ Protemp™46958469582026-10-08
00197998226786Solventum™ Protemp™46955469552026-10-08
00197998226809Solventum™ Paradigm™46995469952026-10-08
00197998226816Solventum™ Paradigm™46994469942026-10-08
00197998226823Solventum™ Paradigm™46993469932026-10-08
00197998226847Solventum™ Garant™77581775812026-10-08
00197998029844Solventum™ Micropore™2770K-12770K-12026-10-05

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
040350772000043M™3M Deutschland GmbHQGO2024-12-02
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