FDA.reportPublic FDA data

Solventum™ Filtek™

Primary DI
00197998102615
Brand
Solventum™ Filtek™
Company
Solventum Germany GmbH
Model
6520S
Catalog number
6520S
Device description
Solventum™ Filtek™ Composite Warmer Silicone Sleeve, 6520S, Silicone Sleeve Replacement
Published
2025-11-03
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
00197998102615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197998102615001979981026151979981026150197998102615

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)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
00197998118654Solventum™ Promogran Prisma™MA032MA0322026-04-10
00197998175190Solventum™ Promogran Prisma™PS2123PS21232026-04-10
00197998291128Solventum™ Promogran Prisma™MA123MA1232026-04-10
00197998291166Solventum™ Promogran Prisma™MA028MA0282026-04-10
00197998291203Solventum™ Promogran Prisma™PS2028PS20282026-04-10
00197998018930Solventum™36716367162026-05-08
00197998018947Solventum™36717367172026-05-08
00197998022579Solventum™76310763102026-05-08
00197998024252Solventum™69940699402026-05-08
00197998024269Solventum™41928419282026-05-08
00197998024276Solventum™41925419252026-05-08
00197998024290Solventum™41926419262026-05-08
00197998024306Solventum™69952699522026-05-08
00197998024313Solventum™69951699512026-05-08
00197998024320Solventum™69950699502026-05-08
00197998024337Solventum™69949699492026-05-08
00197998024344Solventum™69946699462026-05-08
00197998024351Solventum™69945699452026-05-08
00197998024368Solventum™69944699442026-05-08
00197998024375Solventum™69941699412026-05-08

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
00197998327667Solventum™ Filtek™Solventum Germany GmbHQGO2025-04-03
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