FDA.reportPublic FDA data

Power Dental USA

Primary DI
D9431812L00
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
1812L
Catalog number
1812L
Device description
SURGERY KNIVES KOR1/2L LONG BLADE
Published
2021-07-13
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJZKNIFE, MARGIN FINISHING, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJZKnife, Margin Finishing, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9431812L00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal knifeA hand-held dental instrument used to excise the gums and other oral soft tissue during a periodontal intervention (e.g., a gingivectomy involving the excising of the soft tissue wall of a pocket). It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade of various shapes and sizes along the working end. It can be a single-ended or double-ended instrument with a handle at the proximal end or positioned centrally. It is usually made of high-grade stainless steel. 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
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800075604484OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-26
08800075604460OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-19
08800075604477OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-19
08800075604491OSUNG MNDOSUNG MND Co., Ltd.EJZ2024-02-19
10889950110512Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-07-19
10889950110529Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-07-19
10889950121204Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-06-27
10889950043360Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
10889950043377Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
10889950080662Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
10889950080679Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
D943G18010GargPower Dental U.S.A. Inc.EJZ2023-02-28
D943G18120GargPower Dental U.S.A. Inc.EJZ2023-02-28
10889950139353Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139360Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139414Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139421Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139438Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950139513Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
10889950044251HU-FRIEDYHU-FRIEDY MFG. CO., LLCEJZ2022-01-20
10889950133153Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2021-10-08
D9431816D0Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D9431812M00Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D9431816D00Power Dental USAPower Dental U.S.A. Inc.EJZ2021-07-13
D943N1812L00Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.EJZ2021-07-13
D943N1812M00Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.EJZ2021-07-13
D943N1816D00Power Dental U.S.A., Inc.Power Dental U.S.A. Inc.EJZ2021-07-13
D94318020Power Dental USAPower Dental U.S.A. Inc.EJZ2021-06-20
D94318130Power Dental USAPower Dental U.S.A. Inc.EJZ2021-06-20
D94318040Power Dental USAPower Dental U.S.A. Inc.EJZ2021-06-20