FDA.reportPublic FDA data

Power Dental USA

Primary DI
D94341260
Brand
Power Dental USA
Company
Power Dental U.S.A. Inc.
Model
4126
Catalog number
4126
Device description
Power Curettes Serrated Kit..POWER CURETTES SET SERRATED TIPS (5PCS)
Published
2021-06-20
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
DZNInstruments, Dental Hand
EMJELEVATOR, SURGICAL, DENTAL
EMKCurette, Surgical, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1
EMJElevator, Surgical, DentalDental1
EMKCurette, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D94341260PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental elevator, tooth/rootA hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(815)363-8003info@powerdentalgroup.com

Regulatory Flags#

DUNS number
081305064
Device count
1
Premarket exempt
true
Kit
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
B382SD914636200Surgical DirectSurgical Direct, Inc.EMK2026-10-09
B382SD914636210Surgical DirectSurgical Direct, Inc.EMK2026-10-09
B382SD914636230Surgical DirectSurgical Direct, Inc.EMK2026-10-09
B382SD914636240Surgical DirectSurgical Direct, Inc.EMK2026-10-09
00083208130380Scissors Dean T/C CurvedSuncoast Dental, IncDZN2026-10-07
00190776434274MillenniumAvalign Technologies, Inc.EMJ2026-10-06
00816594025448CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
00816594025462CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
00816594025714CONTACT MATRIX SYSTEMZest Anchors, LLCDZN2026-10-01
07908854001750Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
07908854001835Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
07908854018079Supremo InstrumentosANDRE GREGATE BRAGA INSTRUMENTOS LTDADZN2026-09-30
G8791028230DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-09-30
G8791034180DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-09-30
G8791060520DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-09-30
G879LX3CFG0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-09-30
G879LX3DCG0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-09-30
D955BBGA351Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA451Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA551Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BBGA701Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955BDT11Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT21Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT31Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT61Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT71Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT81Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT91Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BONDNG1Paul BandittTerlain Enterprises, Inc.DZN2026-09-25
D955ELE461Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25