FDA.reportPublic FDA data

"Vista 3"" Cotton tip Applicators"

Primary DI
10818207022865
Brand
"Vista 3"" Cotton tip Applicators"
Company
Vista Dental
Model
202003
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
KXFApplicator, Absorbent Tipped, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818207022865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081820702286510818207022865

GMDN Terms#

Term, Definition table
TermDefinition
Dental material application tool, single-useA hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2626369755info@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
10889483563267BALLARD™SUNMED, LLCKXF2026-01-12
10889483563281BALLARD™SUNMED, LLCKXF2026-01-12
10889483563311BALLARD™SUNMED, LLCKXF2026-01-12
10889483563335BALLARD™SUNMED, LLCKXF2026-01-12
10889483563359BALLARD™SUNMED, LLCKXF2026-01-12
07613327680720Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
10889483563274BALLARD™SUNMED, LLCKXF2025-11-17
10889483563298BALLARD™SUNMED, LLCKXF2025-11-17
10889483563328BALLARD™SUNMED, LLCKXF2025-11-17
10889483563342BALLARD™SUNMED, LLCKXF2025-11-17
10889483565520BALLARD™SUNMED, LLCKXF2025-11-17
10889483565537BALLARD™SUNMED, LLCKXF2025-11-17
10889483565544BALLARD™SUNMED, LLCKXF2025-11-17
M220761002Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXF2025-09-11
D832600BA4001MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BF4001MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
10840330701454ProCureTwin Med, LLCKXF2024-11-14
10840330701461ProCureTwin Med, LLCKXF2024-11-14
10840330701478ProCureTwin Med, LLCKXF2024-11-14
10840330701485ProCureTwin Med, LLCKXF2024-11-14
00616784430713"DynaSafety Cotton-Tipped Applicators in Sealed Vial,3"""Dynarex CorporationKXF2024-11-11
00087701406973Good NeighborU.S. COTTON, LLCKXF2024-07-30
00817522013377SwabezeKENTEC MEDICAL, INC.KXF2024-06-28
00817522013353SwabezeKENTEC MEDICAL, INC.KXF2024-06-27
00817522013360SwabezeKENTEC MEDICAL, INC.KXF2024-06-27
00817522013384SwabezeKENTEC MEDICAL, INC.KXF2024-06-27
10817522013343SwabezeKENTEC MEDICAL, INC.KXF2024-06-20