FDA.reportPublic FDA data

House Brand Dentistry

Primary DI
00810132802195
Brand
House Brand Dentistry
Company
Frontier Dental Supply Inc
Model
HSB-300102
Device description
HSB - Amalgam Carrier DE Lar/Lar
Published
2024-01-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810132802195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810132802195008101328021958101328021950810132802195

GMDN Terms#

Term, Definition table
TermDefinition
Dental amalgam carrierA hand-held dental instrument specially designed to collect, transport and deposit amalgam in its plastic state into prepared cavities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
203768304
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810132800610House Brand DentistryHSB-1005612026-02-13
10810132809986House Brand DentistryHSB-1005612026-02-13
00810132808128House Brand DentistryHSB-1091202026-02-10
00810132809446House Brand DentistryHSB-4113012026-02-10
00810132808135House Brand DentistryHSB-1091202026-02-10
10810132809443House Brand DentistryHSB-4113012026-02-10
00810189432451House Brand DentistryHSB-1005742025-09-02
10810189432458House Brand DentistryHSB-1005742025-09-02
00810132800603House Brand DentistryHSB-1005602025-08-29
00810132809941House Brand DentistryHSB-1005702025-08-29
00810189432420House Brand DentistryHSB-1005712025-08-29
00810189432437House Brand DentistryHSB-1005722025-08-29
00810132809958House Brand DentistryHSB-1005602025-08-29
10810132809948House Brand DentistryHSB-1005702025-08-29
10810189432427House Brand DentistryHSB-1005712025-08-29
10810189432434House Brand DentistryHSB-1005722025-08-29
00810132802089House Brand DentistryHSB-1005332025-08-06
00810132802133House Brand DentistryHSB-1005332025-08-06
00810132808050House Brand DentistryHSB-1002352025-08-05
00810132808203House Brand DentistryHSB-1002222025-08-05

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