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
J011130131000N.A.130-131-002020-08-28
J011130137000N.A.130-137-002020-08-28
J011130138000N.A.130-138-002020-08-28
J011130324000N.A.130-324-002020-08-28
J011130634000N.A.130-634-002020-08-28
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J011262412100Carmen®262-412-102016-09-15
J011262415100Carmen®262-415-102016-09-15
J011262421100Carmen®262-421-102016-09-15
J011262422100Carmen®262-422-102016-09-15
J011262423100Carmen®262-423-102016-09-15
J011262424100Carmen®262-424-102016-09-15
J011262431100Carmen®262-431-102016-09-15
J011262432100Carmen®262-432-102016-09-15
J011262433100Carmen®262-433-102016-09-15
J011262434100Carmen®262-434-102016-09-15
J011262442100Carmen®262-442-102016-09-15
J011262443100Carmen®262-443-102016-09-15
J011262444100Carmen®262-444-102016-09-15
J011262450100Carmen®262-450-102016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456203019JMUJMU DENTAL, INCECS2026-07-06
00840456203026JMUJMU DENTAL, INCECS2026-07-06
00840456203033JMUJMU DENTAL, INCECS2026-07-06
00840456203040JMUJMU DENTAL, INCECS2026-07-06
00840456203057JMUJMU DENTAL, INCECS2026-07-06
00840456203064JMUJMU DENTAL, INCECS2026-07-06
00840456203071JMUJMU DENTAL, INCECS2026-07-06
00840456203088JMUJMU DENTAL, INCECS2026-07-06
00840456203095JMUJMU DENTAL, INCECS2026-07-06
00858813002175PlatypusGLENROE, LLCECS2026-06-01
00858813002182PlatypusGLENROE, LLCECS2026-06-01
00858813002199PlatypusGLENROE, LLCECS2026-06-01
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
00190707193324Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193331Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193348Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193355Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193362Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193379Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193386Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00190707193393Ortho Technology®Ortho Organizers, Inc.ECS2025-10-23
00371347019797Advance Dental ProductsThe Atlanta Dental Supply CompanyECS2025-10-02
00371347019803Advance Dental ProductsThe Atlanta Dental Supply CompanyECS2025-10-02
00889813066041Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCECS2024-11-30
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00850058951379Amtouch Aligner ChewiesAMERICAN MEDICAL & HOSPITAL SUPPLY CO., INC.ECS2024-10-08