FDA.reportPublic FDA data

Power Dental USA

Primary DI
D9432054S00
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
2054S
Catalog number
2054S
Device description
OSTEOTOME 3.0mm STR (8-10-13-15-18mm) CONCAVE
Published
2021-07-13
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
GFIOSTEOTOME, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFIOsteotome, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D9432054S00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental rongeurA strongly constructed dental instrument that is used in the removal of the sharp edges of the alveolar crest of the bone following tooth extraction. It has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws that bite (cut) through the bone tissue. It is 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
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
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

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