FDA.reportPublic FDA data

Power Dental U.S.A., Inc.

Primary DI
D943N1416BE00
Brand
Power Dental U.S.A., Inc.
Company
Power Dental U.S.A. Inc.
Model
N1416BE
Catalog number
N1416BE
Device description
COLUMBIA 13/14 BLACK EDITION EDGE
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
EMKCURETTE, SURGICAL, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMKCurette, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D943N1416BE00PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal curetteA hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. 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
G8791021780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102178H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028180DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102818S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102818STIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102818TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028190DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102819S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102819STIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102819TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028200DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102820S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102820STIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102820TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028210DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102821S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102821STIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G879102821TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
G8791028220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMK2026-08-15
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B382SD48800210Surgical DirectSurgical Direct, Inc.EMK2026-08-03
B382SD48800220Surgical DirectSurgical Direct, Inc.EMK2026-08-03
B382S344441010Surgical DirectSurgical Direct, Inc.EMK2026-07-31
B382SD914631720Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914631770Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914631780Surgical DirectSurgical Direct, Inc.EMK2026-07-27