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
D94320240Power Dental USA202420242021-06-20
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
D94315240Power Dental USA152415242021-06-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9213571010Surgical DirectSurgical Direct, Inc.EMK2026-08-07
B382SD9213571070Surgical DirectSurgical Direct, Inc.EMK2026-08-07
B382SD921480060Surgical DirectSurgical Direct, Inc.EMK2026-08-07
B382SD9238971060Surgical DirectSurgical Direct, Inc.EMK2026-08-07
B382SD934444090Surgical DirectSurgical Direct, Inc.EMK2026-08-07
00190776408688MillenniumAvalign Technologies, Inc.EMJ2026-08-03
B382SD48800210Surgical DirectSurgical Direct, Inc.EMK2026-08-03
B382SD48800220Surgical DirectSurgical Direct, Inc.EMK2026-08-03
B382S344441010Surgical DirectSurgical Direct, Inc.EMK2026-07-31
00198506092688ELMED INCORPORATEDELMED INCORPORATEDDZN2026-07-28
B382SD914631720Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914631770Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914631780Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914631790Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914638200Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD914638210Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD9146461000Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD9146531550Surgical DirectSurgical Direct, Inc.EMK2026-07-27
B382SD902511300Surgical DirectSurgical Direct, Inc.EMK2026-07-24
E0HM39MI2071Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
E0HM39MI2081Bone ManagementHager & Meisinger Gesellschaft mit beschränkter HaftungDZN2026-07-24
00190776400224MillenniumAvalign Technologies, Inc.EMJ2026-07-21
00190776403706MillenniumAvalign Technologies, Inc.EMJ2026-07-21
00190776403867MillenniumAvalign Technologies, Inc.DZN2026-07-21
00190776395506MillenniumAvalign Technologies, Inc.EMJ2026-07-14
00190776395513MillenniumAvalign Technologies, Inc.EMJ2026-07-14
00190776395544MillenniumAvalign Technologies, Inc.EMJ2026-07-14
00190776395551MillenniumAvalign Technologies, Inc.EMJ2026-07-14
00190776395377MillenniumAvalign Technologies, Inc.EMJ2026-07-13
B382SD9143681000Surgical DirectSurgical Direct, Inc.EMK2026-07-13