FDA.reportPublic FDA data

N.A.

Primary DI
J011026355000
Brand
N.A.
Company
DENTAURUM GmbH & Co.KG
Model
026-355-00
Device description
Molar band seater, plastic
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJBHANDLE, INSTRUMENT, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011026355000PrimaryHIBCC0

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
J011302106100tomas®302-106-102016-09-15
J011302106300tomas®302-106-302016-09-15
J011302108100tomas®302-108-102016-09-15
J011302108300tomas®302-108-302016-09-15
J011302110100tomas®302-110-102016-09-15
J011302110300tomas®302-110-302016-09-15
J011302206100tomas®302-206-102016-09-15
J011302206300tomas®302-206-302016-09-15
J011302208100tomas®302-208-102016-09-15
J011302208300tomas®302-208-302016-09-15
J011302210100tomas®302-210-102016-09-15
J011302210300tomas®302-210-302016-09-15
J011790261020equilibrium®790-261-022016-09-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08404535030822Brasseler USAPeter Brasseler Holdings, LLCEJB2026-07-13
08961104622142Strip PlacerMELPEX BEAUTY INSTRUMENTSEJB2026-05-21
G149TBSB3100TBS BASICSACME ENTERPRISE.EJB2026-05-16
08809260472853TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472860TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472877TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472884TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472891TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472907TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472914TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
08809260472921TRAUSSaeshin Precision Co., Ltd.EJB2026-05-07
G149NP360100NPSACME ENTERPRISE.EJB2026-05-01
G149NP380630NPSACME ENTERPRISE.EJB2026-05-01
EZPF26179500HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179510HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179550HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179560HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179570HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179580HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
EZPF26179590HELMUT ZEPFHelmut Zepf Medizintechnik GmbHEJB2026-04-13
10371347017721Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
10371347017745Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
08800075626905OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627230OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627247OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627254OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627674OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627681OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627735OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03
08800075627742OSUNG MNDOSUNG MND Co., Ltd.EJB2025-11-03