FDA.reportPublic FDA data

Power Dental USA

Primary DI
D9432807PA00
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
2807PA
Catalog number
2807PA
Device description
BURNISHERS B21 LARGE PARAGON 3.5 / 2.4 MM TOLERANCE +- 2 MM
Published
2021-07-13
Public version status
Update
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
EKJBURNISHER, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKJBurnisher, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9432807PA00PrimaryHIBCC0

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
00348783009361Premier BurnisherPREMIER DENTAL PRODUCTS COMPANYEKJ2026-03-17
00840018667389Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-10
00840018671508Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-10
00840018672314Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-10
00840018665729Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-09
00840018666139Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-02-09
00840018662247Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-01-29
00840018662896Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKJ2026-01-29
05010058178090InstrapacROBINSON HEALTHCARE LIMITEDEKJ2025-06-23
00889813065884Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065891Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065907Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065914Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065921Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065945Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813066157Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-11-30
00889813065938Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKJ2024-10-01
00813677025159PDT, Inc.PDT, INC.EKJ2024-09-11
00813677025166PDT, Inc.PDT, INC.EKJ2024-09-11
00842517118652Karl SchumacherKarl Schumacher Dental, LLCEKJ2024-05-06
00842517118669Karl SchumacherKarl Schumacher Dental, LLCEKJ2024-05-06
00842517118676Karl SchumacherKarl Schumacher Dental, LLCEKJ2024-05-06
08800075604774OSUNG MNDOSUNG MND Co., Ltd.EKJ2024-03-04
08800075604750OSUNG MNDOSUNG MND Co., Ltd.EKJ2024-02-21
08800075604767OSUNG MNDOSUNG MND Co., Ltd.EKJ2024-02-21
08800075624000OSUNG MNDOSUNG MND Co., Ltd.EKJ2024-02-21
08964003163297NivoB. Ali ImpexEKJ2024-01-27
08964003163303NivoB. Ali ImpexEKJ2024-01-27
10889950112929Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEKJ2023-07-19
10889950114046Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEKJ2023-06-27