FDA.reportPublic FDA data

Power Dental U.S.A., Inc.

Primary DI
D943N4406N00
Brand
Power Dental U.S.A., Inc.
Company
Power Dental U.S.A. Inc.
Model
N4406N
Catalog number
N4406N
Device description
BONE RONGEURS BEYER DOUBLE ACTION MINI RUSKIN 15.5 cm
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
EMHFORCEPS, RONGEUR, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMHForceps, Rongeur, SurgicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D943N4406N00PrimaryHIBCC0

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
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
D955RON811S1Paul BandittTerlain Enterprises, Inc.EMH2026-09-25
D955RONBLU1Paul BandittTerlain Enterprises, Inc.EMH2026-09-25
D955RONMC0Paul BandittTerlain Enterprises, Inc.EMH2026-09-25
B76884850220Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-06-05
B7685631130Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-06-02
B7688371010Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-06-02
B7688386020Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-04-23
B7688441030Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-04-23
B76884751040Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-04-23
B76884754320Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2026-04-23
B7688441020Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-12-31
B7688457751630Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-12-31
B7688457751030Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-11-21
B76884332520Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-11-13
B7688452420Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-11-03
B76884850320Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884850420Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884850520Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884852320Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884852420Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B76884852520Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-30
B7685636870Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-23
B7685636880Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-07-23
B76884342320Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-06-20
B76884342420Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-06-20
B7688365450Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-05-23
B7688439220Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-05-23
B7685638140Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-05-20
B7688378040Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-05-20
B7688457651620Buxton BioMedicalBUXTON BIOMEDICAL, INC.EMH2025-05-07