FDA.reportPublic FDA data

Power Dental U.S.A., Inc.

Primary DI
D943N4308
Brand
Power Dental U.S.A., Inc.
Company
Power Dental U.S.A. Inc.
Model
N4308
Catalog number
N4308
Device description
AMALGAM CARRIERS S/M 2.0/2.8 mm outside Diameter
Published
2021-06-20
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

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
D943N4308PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+1(815)363-8003info@mydentalusa.com

Regulatory Flags#

DUNS number
081305064
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D943ORCAA0Power Dental USAORCAAORCAA2021-06-20
D94367350Power Dental USA673567352021-06-20
D94367380Power Dental USA673867382021-06-20
D94367390Power Dental USA673967392021-06-20
D94367410Power Dental USA674167412021-06-20
D94367430Power Dental USA674367432021-06-20
D9431007E0Power Dental USA1007E1007E2021-07-13
D94315240Power Dental USA152415242021-06-20
D94335090Power Dental USA350935092021-06-20
D9434826XAS0Power Dental USA4826XAS4826XAS2021-07-13
D94362100Power Dental USA621062102021-06-20
D94364470Power Dental USA644764472022-01-08
D943813050Power Dental USA8130-58130-52021-07-13
D943DCAM0Power Dental USADCAMDCAM2021-07-13
D943DCAM30Power Dental USADCAM3DCAM32021-07-13
D943KIM10Power Dental USAKIM-1KIM-12022-07-12
D943KIM120Power Dental USAKIM-12KIM-122022-07-12
D943KIM20Power Dental USAKIM-2KIM-22022-07-12
D943KIM240Power Dental USAKIM-24KIM-242021-07-13
D943KIM30Power Dental USAKIM-3KIM-32022-07-12

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
00810132802188House Brand DentistryHouse Brand DentistryEKI2024-01-29
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