FDA.reportPublic FDA data

Power Dental USA

Primary DI
D94369610
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
6961
Catalog number
6961
Device description
MIRROR WITH MIRROR HANDLE, MIRROR #5 C/S FRONT SURFACE WITH MIRROR HANDLE 4EZ C/S (6951+6910) FOR USE ONLY WITH POWER DENTAL USA MIRRORS / HANDLES. WE DO NOT GUARANTEE FIT OF OTHER MANUFACTURERS MIRRORS/HANDLES
Published
2021-06-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FTXMIRROR, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTXMirror, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D94369610PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tumour-therapy nanoparticle suspension, magnetic hyperthermia/thermoablationAn implantable nanomaterial designed to be locally administered into a tumour or tumour bed (e.g., brain tumour) and to be subsequently heated by an external alternating magnetic field whereby the heat released by the material is intended to destroy surrounding tumour cells (thermoablation), or alternatively sensitize tumour cells [hyperthermia] to enhance the efficacy of concomitant radiotherapy or chemotherapy. It is in the form of an aqueous suspension containing superparamagnetic iron oxide nanoparticles.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
081305064
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D9431225M0Power Dental USA1225M1225M2021-07-13
D94312400Power Dental USA124012402021-06-20
D9431610R0Power Dental USA1610R1610R2021-07-13
D9431610T0Power Dental USA1610T1610T2021-07-13
D9431611R0Power Dental USA1611R1611R2021-07-13
D9431612R0Power Dental USA1612R1612R2021-07-13
D9431613R0Power Dental USA1613R1613R2021-07-13
D94316140Power Dental USA161416142021-06-20
D9431614T0Power Dental USA1614T1614T2021-07-13
D94316150Power Dental USA161516152021-06-20
D9431615R0Power Dental USA1615R1615R2021-07-13
D9431615T0Power Dental USA1615T1615T2021-07-13
D94316160Power Dental USA161616162021-06-20
D9431617R0Power Dental USA1617R1617R2021-07-13
D9434101SB0Power Dental USA4101SB4101SB2021-06-20
D9434102SB0Power Dental USA4102SB4102SB2021-06-20
D9434126B0Power Dental USA4126B4126B2021-06-20
D94312390Power Dental USA123912392021-06-20
D9431614R0Power Dental USA1614R1614R2021-07-13
D94315240Power Dental USA152415242021-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613105877MSI Precision Specialty InstrumentsMed Saver, Inc.FTX2025-03-21
00887482113974Symmetry HouseASPEN SURGICAL PRODUCTS, INC.FTX2024-08-12
00190776319557MILLENNIUMAvalign Technologies, Inc.FTX2023-09-28
D9436951D0Power Dental USAPower Dental U.S.A. Inc.FTX2023-02-28
D94369640Power Dental USAPower Dental U.S.A. Inc.FTX2023-02-28
D943G69620GargPower Dental U.S.A. Inc.FTX2023-02-28
14026704805171PILLINGTELEFLEX INCORPORATEDFTX2022-12-08
54026704805179PILLINGTELEFLEX INCORPORATEDFTX2022-12-08
D9436968Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-12
D943N6968Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-12
D9436950S0Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D94369540Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D94369690Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D9436913Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D9436950S00Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D9436953Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D9436954Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D9436955Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D9436956Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D9436969Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D943N6953Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D943N6954Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D943N6955Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D943N6956Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
D943N6969Power Dental USAPower Dental U.S.A. Inc.FTX2022-01-08
00190776044268AvalignAvalign Technologies, Inc.FTX2021-11-03
D943N6952Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.FTX2021-07-17
D943193010Power Dental USAPower Dental U.S.A. Inc.FTX2021-07-13
D9436920BE0Power Dental USAPower Dental U.S.A. Inc.FTX2021-07-13
D94369710Power Dental USAPower Dental U.S.A. Inc.FTX2021-07-13