FDA.reportPublic FDA data

House Brand Dentistry

Primary DI
00810132802188
Brand
House Brand Dentistry
Company
House Brand Dentistry
Model
HSB-300101
Device description
HSB - Amalgam Carrier DE Reg/Reg
Published
2024-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00810132802188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810132802188008101328021888101328021880810132802188

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810132809436House Brand DentistryHSB-4113002025-05-14
10810132809450House Brand DentistryHSB-4113022025-05-14
10810132809467House Brand DentistryHSB-4113032025-05-14
10810132809320House Brand DentistryHSB-4112082025-05-09
10810132809351House Brand DentistryHSB-4112112025-05-09
10810132809382House Brand DentistryHSB-4112142025-05-09
10810132809399House Brand DentistryHSB-4112152025-05-09
10810132808392House Brand DentistryHSB-4111082025-05-08
10810132808415House Brand DentistryHSB-4111102025-05-08
10810132808446House Brand DentistryHSB-4111132025-05-08
10810132808477House Brand DentistryHSB-4111172025-05-08
10810132808569House Brand DentistryHSB-4111282025-05-08
10810132808651House Brand DentistryHSB-4111392025-05-08
10810132808675House Brand DentistryHSB-4111412025-05-08
10810132808910House Brand DentistryHSB-4111782025-05-08
10810132808941House Brand DentistryHSB-4111782025-05-08
10810132808958House Brand DentistryHSB-4111792025-05-08
10810132809030House Brand DentistryHSB-4111502025-05-08
10810132809078House Brand DentistryHSB-4111832025-05-08
10810132809085House Brand DentistryHSB-4111842025-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783008760Premier Amalgam CarrierPREMIER DENTAL PRODUCTS COMPANYEKI2026-03-17
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
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
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
D105SKU1312551SurgiMac Surgimac LLCEKI2024-03-18
08800075626325OSUNG MNDOSUNG MND Co., Ltd.EKI2024-02-23
08800075603531OSUNG MNDOSUNG MND Co., Ltd.EKI2024-02-21
08800075603548OSUNG MNDOSUNG MND Co., Ltd.EKI2024-02-21
08800075603555OSUNG MNDOSUNG MND Co., Ltd.EKI2024-02-21
00810132803680House Brand DentistryHouse Brand DentistryEKI2024-01-30
00810132802195House Brand DentistryHouse Brand DentistryEKI2024-01-29
D9281071310RETROGRADE AMALGAM CARRIER 1MMW.H. Holden, Inc.EKI2023-11-05
D9281071320RETROGRADE AMALGAM CARRIER 2MMW.H. Holden, Inc.EKI2023-11-05
EZPF26426450HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEKI2022-12-06
EZPF26428010HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEKI2022-12-06