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
00197998326615Solventum™ Adaptic™MAD003MAD0032026-08-26
00197998326653Solventum™ Adaptic™MAD042MAD0422026-08-26
00197998367281Solventum™ Adaptic™MAD013MAD0132026-08-26
00197998367359Solventum™ Adaptic™MAD023MAD0232026-08-26
00197998367427Solventum™ Adaptic™MAD062MAD0622026-08-26
00197998152252Solventum™ Tegaderm™90600906002026-08-23
00197998152283Solventum™ Tegaderm™90601906012026-08-23
00197998152313Solventum™ Tegaderm™90602906022026-08-23
00197998152344Solventum™ Tegaderm™90603906032026-08-23
00197998152375Solventum™ Tegaderm™90604906042026-08-23
00197998305801Solventum™ Tegaderm™90817908172026-08-23
00197998305832Solventum™ Tegaderm™90815908152026-08-23
00197998305863Solventum™ Tegaderm™90805908052026-08-23
00197998305894Solventum™ Tegaderm™90803908032026-08-23
00197998305924Solventum™ Tegaderm™90802908022026-08-23
00197998305955Solventum™ Tegaderm™90801908012026-08-23
00197998305986Solventum™ Tegaderm™90800908002026-08-23
00197998415500Solventum™ Tegaderm™90613906132026-08-23
00197998415548Solventum™ Tegaderm™90611906112026-08-23
00197998415586Solventum™ Tegaderm™90612906122026-08-23

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