FDA.reportPublic FDA data

Power Dental USA

Primary DI
D94321160
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
2116
Catalog number
2116
Device description
CHISELS C8/9
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
EMQHOE, PERIODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMQHoe, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D94321160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, scissors-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
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
00840018661318Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEMQ2026-01-28
D928400512RD0CHISEL 7-10 D/E ROUND HANDLEW.H. Holden, Inc.EMQ2026-01-06
10889950133603Hu-FriedyHU-FRIEDY MFG. CO., LLCEMQ2025-12-19
00841336108738Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCEMQ2025-11-11
00841013116513American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EMQ2024-11-06
00841013116537American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EMQ2024-11-06
10889950023102Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-06-27
10889950025526Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-06-27
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10889950025595Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950030636Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
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10889950033200Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950033361Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950033378Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950089863Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950091897Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950092764Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950092849Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950092979Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07
10889950096922Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEMQ2023-04-07