FDA.reportPublic FDA data

Power Dental USA

Primary DI
D9431812M00
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
1812M
Catalog number
1812M
Device description
SURGERY KNIVES KOR 1/2 MICRO 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

Related Records

Contact Domains

Product Codes

CodeName
EJZKNIFE, MARGIN FINISHING, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EJZKnife, Margin Finishing, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D9431812M00PrimaryHIBCC0

GMDN Terms

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
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

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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

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10889950080679Hu-Friedy MFG Co., LLC.HU-FRIEDY MFG. CO., LLCEJZ2023-04-07
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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
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10889950139513Hu-FriedyHU-FRIEDY MFG. CO., LLCEJZ2022-10-17
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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
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