FDA.reportPublic FDA data

Power Dental U.S.A., Inc.

Primary DI
D943N78260
Brand
Power Dental U.S.A., Inc.
Company
Power Dental U.S.A. Inc.
Model
N7826-0
Catalog number
N7826-0
Device description
"""C&L SINUS KIT, CRESTAL & LATERAL UNIVERSAL KIT"
Published
2021-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D943N78260PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. 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
Premarket exempt
true
No natural rubber latex
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
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10888277689206MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689213MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689220MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689237MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689244MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
20888277688978MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10080196320899MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321407MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321414MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321438MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321452MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321469MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321476MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321483MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321490MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10888277689183MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321445MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-24
00190776431587MillenniumAvalign Technologies, Inc.MDM2026-09-22
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00850088713893PRINCETONPrinceton Medical Group, Inc.MDM2026-09-22
00888867574489Arthrex®ARTHREX, INC.MDM2026-09-18
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10888277688896MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688902MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18