FDA.reportPublic FDA data

N.A.

Primary DI
J011051022000
Brand
N.A.
Company
DENTAURUM GmbH & Co.KG
Model
051-022-00
Device description
Exchange Tip,Straight
Published
2016-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ECTDRIVER, BAND, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECTDriver, Band, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011051022000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal band pusherA hand-held dental instrument intended to be used by an orthodontist for positioning and adapting orthodontic metal bands on teeth. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No special storage conditions required

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-3946info@dentaurum-us.com

Regulatory Flags#

DUNS number
315427286
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011250001400ceraMotion®250-001-402016-09-15
J011250002200ceraMotion®250-002-202016-09-15
J011250002400ceraMotion®250-002-402016-09-15
J011250003200ceraMotion®250-003-202016-09-15
J011250003400ceraMotion®250-003-402016-09-15
J011250004200ceraMotion®250-004-202016-09-15
J011250004400ceraMotion®250-004-402016-09-15
J011250005200ceraMotion®250-005-202016-09-15
J011250005400ceraMotion®250-005-402016-09-15
J011250006200ceraMotion®250-006-202016-09-15
J011250006400ceraMotion®250-006-402016-09-15
J011250018200ceraMotion®250-018-202016-09-15
J011250019200ceraMotion®250-019-202016-09-15
J011250021200ceraMotion®250-021-202016-09-15
J011250021400ceraMotion®250-021-402016-09-15
J011250022200ceraMotion®250-022-202016-09-15
J011250022400ceraMotion®250-022-402016-09-15
J011250023200ceraMotion®250-023-202016-09-15
J011250023400ceraMotion®250-023-402016-09-15
J011250024200ceraMotion®250-024-202016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806145440129Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145440136Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145440143Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145440150Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145440167Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145440174Orthodontic DriverDENTOS Inc.ECT2025-05-02
08806145484086Orthodontic DriverDENTOS Inc.ECT2025-05-02
00371347018325Advance Dental ProductsThe Atlanta Dental Supply CompanyECT2025-01-02
08800041038121MalletSurgident Co.,Ltd.ECT2023-10-18
08800041039128Tac Remover DriverSurgident Co.,Ltd.ECT2023-10-18
08800041039135Tac ApplicatorSurgident Co.,Ltd.ECT2023-10-18
08800041039807Tac Remover DriverSurgident Co.,Ltd.ECT2023-10-18
08800041053469Tac ApplicatorSurgident Co.,Ltd.ECT2023-10-18
08800046045797SA-001GNI Co.,LtdECT2023-10-11
08800046045810SA-002GNI Co.,LtdECT2023-10-11
08800046045827SA-003GNI Co.,LtdECT2023-10-11
08800046045834SA-005GNI Co.,LtdECT2023-10-11
08800046045858SA-006GNI Co.,LtdECT2023-10-11
08800046045865SA-004GNI Co.,LtdECT2023-10-11
08800046045872SA-020GNI Co.,LtdECT2023-10-11
08800046045889SA-010GNI Co.,LtdECT2023-10-11
08800046046695SA-100GNI Co.,LtdECT2023-10-11
08800041052455Driver HandleSurgident Co.,Ltd.ECT2022-12-08
08800041052462Driver HandleSurgident Co.,Ltd.ECT2022-12-08
08809162706391Simple LineDentium Co., Ltd.ECT2020-05-14
08809162705141Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14
08809162705158Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14
08809162705165Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14
08809162705189Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14
08809162705516Implantium, SuperlineDentium Co., Ltd.ECT2020-05-14