FDA.reportPublic FDA data

Power Dental USA

Primary DI
D943N6968
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
N6968
Catalog number
N6968
Device description
MIRROR WITH MIRROR HANDLE #5 DOUBLE END C/S FRONT SURFACE WITH MIRROR HANDLE THIN OCTAGON C/S WITH RULER (6951D+6908A) FOR USE ONLY WITH POWER DUSA MIRRORS/HANDLES. WE DO NOT GUARANTEE FIT OF OTHER MANUFACTURERS MIRRORS/HANDLES
Published
2022-01-12
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
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
D943N6968PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental mirror, reusableA hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. 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
D94320240Power Dental USA202420242021-06-20
D94341260Power Dental USA412641262021-06-20
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
D94367140Power Dental USA671467142021-06-20
D94367420Power Dental USA674267422021-06-20
D9436710E0Power Dental USA6710E6710E2021-07-13
D94367310Power Dental USA673167312021-06-20
D94367320Power Dental USA673267322021-06-20
D94367150Power Dental USA671567152021-06-20
D9436716Power Dental USA671667162021-06-20
D9436733Power Dental USA673367332021-06-20
D9436734Power Dental USA673467342021-06-20
D9436740Power Dental USA674067402021-06-20
D9436750Power Dental USA675067502022-01-08
D9431007E0Power Dental USA1007E1007E2021-07-13

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
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
D9436911BE0Power Dental USAPower Dental U.S.A. Inc.FTX2021-07-13