FDA.reportPublic FDA data

Disposable .80mm MTA Carrier

Primary DI
10818207023725
Brand
Disposable .80mm MTA Carrier
Company
Vista Dental
Model
807017
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
EKICarrier, Amalgam, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKICarrier, Amalgam, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818207023725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081820702372510818207023725

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
G149TBSB8180TBS BASICSACME ENTERPRISE.EKI2026-05-18
G149TBSB8190TBS BASICSACME ENTERPRISE.EKI2026-05-18
00371347023428Advance Dental ProductsThe Atlanta Dental Supply CompanyEKI2026-04-14
00348783008753Premier Amalgam CarrierPREMIER DENTAL PRODUCTS COMPANYEKI2026-03-18
00348783008760Premier Amalgam CarrierPREMIER DENTAL PRODUCTS COMPANYEKI2026-03-17
08800075627698OSUNG MNDOSUNG MND Co., Ltd.EKI2025-11-03
07898078650134SPEED GUNAngelus Industria de Produtos Odontologicos S AEKI2025-03-20
07898078657423SPEED GUNAngelus Industria de Produtos Odontologicos S AEKI2025-03-20
07898078659427EdgeUtopia RRM Dispensing GunAngelus Industria de Produtos Odontologicos S AEKI2025-03-20
00813677023063PDT, Inc.PDT, INC.EKI2024-07-02
00813677023087PDT, Inc.PDT, INC.EKI2024-07-02
00813677023070PDT, Inc.PDT, INC.EKI2024-07-01
00813677023124PDT, Inc.PDT, INC.EKI2024-06-27
00813677024978PDT, Inc.PDT, INC.EKI2024-06-27
00840105223160ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223177ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223184ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223191ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223207ZOLL DENTALZoll-DentalEKI2024-05-31
D105SKU1312510SurgiMac Surgimac LLCEKI2024-05-08
D105SKU131257H02SurgiMac Surgimac LLCEKI2024-04-22
D105SKU131257H13SurgiMac Surgimac LLCEKI2024-04-22
10889950142407Amalgam Carrier, Reg/MiniHU-FRIEDY MFG. CO., LLCEKI2024-04-02
10889950142414Amalgam Carrier, Reg/LrgHU-FRIEDY MFG. CO., LLCEKI2024-04-02
10889950142421Amalgam Carrier, Reg/JumboHU-FRIEDY MFG. CO., LLCEKI2024-04-02
10889950142438Amalgam WellHU-FRIEDY MFG. CO., LLCEKI2024-04-02
D105SKU1312550SurgiMac Surgimac LLCEKI2024-03-18
D105SKU1312551SurgiMac Surgimac LLCEKI2024-03-18
08800075626325OSUNG MNDOSUNG MND Co., Ltd.EKI2024-02-23
08800075603531OSUNG MNDOSUNG MND Co., Ltd.EKI2024-02-21