FDA.reportPublic FDA data

Vista 240V 6cc Syringe Warmer

Primary DI
10818207023107
Brand
Vista 240V 6cc Syringe Warmer
Company
Vista Dental
Model
240301
Published
2022-09-01
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
00818207023100Direct MarkingGS10
10818207023107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00818207023100008182070231008182070231000818207023100
1081820702310710818207023107

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2626369755info@vista-dental.com

Regulatory Flags#

DUNS number
036623932
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818207020840ZrP Syringe Kit905782021-01-29
10818207024920Endo Sealer Solvent3170332026-04-22
10818207024944Endo Sealer Solvent Sample317033-M2026-04-22
00850194007862Desensify12019-12-13
00850194007893Omni Etch Ceramic Etch and Silane12019-12-13
10818207024937EdgeUtopi BC Solvent 108182070249372025-03-17
10818207025071Endocator Starter Kit4077302025-11-07
10818207025088Endocator Swabs (20pk)4077312025-11-07
10818207025064ReminGelRGEL30002025-10-09
10818207020205Vista-Cal Standard Kit5026002018-07-31
10818207020878Velvet Etch 5033152021-05-13
30818207020872Velvet Etch 5033002021-05-13
00850194007787Purify+ Gel 5 Pack12019-12-13
00850194007794Purify+ Liquid 5 Pack12019-12-13
00850194007954Purify+ Gel Single Pack12019-12-13
00850194007961Purify+ Liquid Single Pack12019-12-13
20818207020202Vista-Cal Refill Kit5026012018-07-31
00850194007466RE-GEN Cleanser1907192016-06-16
00818207020208Vista-Cal 2 pack Foil Pouch36272018-08-28
10818207024968Traxodent Gel AlCl - Bulk Syringe Kit90071012025-06-30

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
040350772000043M™3M Deutschland GmbHQGO2024-12-02
10818207022162Phasor KitVista 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