FDA.report

Power Dental USA

Primary DI
D9436967
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
6967
Catalog number
6967
Device description
MIRROR WITH MIRROR HANDLE #4 MIRROR C/S FRONT SURFACE WITH MIRROR HANDLE 6EZ C/S (6950+6911) FOR USE ONLY WITH POWER DUSA 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
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FTXMIRROR, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
FTXMirror, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D9436967PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
00194613105877MSI Precision Specialty InstrumentsMed Saver, Inc.FTX2025-03-21
00887482113974Symmetry Surgical®SYMMETRY SURGICAL 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
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
D9436920BE0Power Dental USAPower Dental U.S.A. Inc.FTX2021-07-13
D94369710Power Dental USAPower Dental U.S.A. Inc.FTX2021-07-13
D9436911BE0Power Dental USAPower Dental U.S.A. Inc.FTX2021-07-13
D9436951DB0Power Dental USAPower Dental U.S.A. Inc.FTX2021-07-13