FDA.reportPublic FDA data

Vista Single Medium Fluoride Trays

Primary DI
10818207021882
Brand
Vista Single Medium Fluoride Trays
Company
Vista Dental
Model
205102
Published
2022-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMTTray, Fluoride, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMTTray, Fluoride, DisposableDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818207021882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081820702188210818207021882

GMDN Terms#

Term, Definition table
TermDefinition
Fluoride gel trayA device typically made of styrofoam that is used to apply fluoride topically to the teeth. The device is designed to conform to the human mouth; a patient bites down on the device after it has been filled with a fluoride gel or solution for application.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
262-636-9755info@vista-dental.com

Regulatory Flags#

DUNS number
036623932
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10818207024975Traxodent Gel AlCl - Sample Pack90071042025-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850043381570Buffalo DentalBuffalo Dental Manufacturing Co., Inc.KMT2026-04-10
00850043381587Buffalo DentalBuffalo Dental Manufacturing Co., Inc.KMT2026-04-10
00889813067857Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067864Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067871Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067888Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067895Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067901Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067918Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067925Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067932Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067949Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00889813067956Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067854Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067861Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067878Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067885Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067892Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067908Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067915Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067922Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067939Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067946Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
10889813067953Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCKMT2025-07-02
00766054003007Turbo-CRESSENTIAL DENTAL SYSTEMS, INC.KMT2025-04-04
D956FLTRAY25Fluoride Gel Tray 25-pkD.S.I DENTAL SOLUTIONS LTDKMT2024-07-01
00810339031282SAFE DENTBGSS Company Inc.KMT2024-05-01
00810339031428SAFE DENTBGSS Company Inc.KMT2024-05-01
00810339031480SAFE DENTBGSS Company Inc.KMT2024-05-01
00810339031299SAFE DENTBGSS Company Inc.KMT2024-05-01