FDA.reportPublic FDA data

N.A.

Primary DI
J011024300000
Brand
N.A.
Company
DENTAURUM GmbH & Co.KG
Model
024-300-00
Device description
Mershon band pusher
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
ECSPUSHER, BAND, ORTHODONTIC

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011024300000PrimaryHIBCC0

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

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00858813002205PlatypusGLENROE, LLCECS2026-06-01
00840018674639Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCECS2026-05-05
00840018662087Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCECS2026-01-29
00840018662155Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCECS2026-01-29
00190707193317Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
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00190707193386Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193393Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
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00371347019803Advance Dental ProductsThe Atlanta Dental Supply CompanyECS2025-10-02
00889813066041Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCECS2024-11-30
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00885797097293SchweickhardtRmo, Inc.ECS2024-08-19
00840105223597ZOLL DENTALZoll-DentalECS2024-07-29
00843471151273Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
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00843471151310Young SpecialtiesYoung Innovations, Inc.ECS2024-07-11
07908611206053ORTHOCHEWIEORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECS2024-02-27
08800075622747OSUNG MNDOSUNG MND Co., Ltd.ECS2024-02-19