FDA.reportPublic FDA data

N.A.

Primary DI
J011074200000
Brand
N.A.
Company
DENTAURUM GmbH & Co.KG
Model
074-200-00
Device description
OrthoSafe sports guard / Assortment - The safe and comfortable guard for all types of sports / For further information please visit our online-shop on www.dentaurum.de
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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EEJGUARD, DISK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEJGuard, DiskDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011074200000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance removerA small hook-shaped device designed for manual removal of orthodontic devices (e.g., retainer, teeth positioner) from around the teeth. It is made of plastic materials. This is a single-patient, reusable device.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011254000020ceraMotion®254-000-022026-07-25
J011254000100ceraMotion®254-000-102026-07-25
J011254000500ceraMotion®254-000-502026-07-25
J011254001020ceraMotion®254-001-022026-07-25
J011254001100ceraMotion®254-001-102026-07-25
J011254001500ceraMotion®254-001-502026-07-25
J011254002020ceraMotion®254-002-022026-07-25
J011254002100ceraMotion®254-002-102026-07-25
J011254002500ceraMotion®254-002-502026-07-25
J011254004020ceraMotion®254-004-022026-07-25
J011254004100ceraMotion®254-004-102026-07-25
J011254006020ceraMotion®254-006-022026-07-25
J011254006100ceraMotion®254-006-102026-07-25
J011254008020ceraMotion®254-008-022026-07-25
J011254008100ceraMotion®254-008-102026-07-25
J011254010020ceraMotion®254-010-022026-07-25
J011254010100ceraMotion®254-010-102026-07-25
J011254012020Triceram®254-012-022026-07-25
J011254014020Triceram®254-014-022026-07-25
J011254300020ceraMotion®254-300-022026-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840326403051The Orthodontic StoreYoung Innovations, Inc.EEJ2022-11-24
10840326403058The Orthodontic StoreYoung Innovations, Inc.EEJ2022-11-24
J01174206000N.A.DENTAURUM GmbH & Co.KGEEJ2018-12-06
J011074000000N.A.DENTAURUM GmbH & Co.KGEEJ2016-09-15
J011074001000N.A.DENTAURUM GmbH & Co.KGEEJ2016-09-15
J011074100000N.A.DENTAURUM GmbH & Co.KGEEJ2016-09-15
J011074203000N.A.DENTAURUM GmbH & Co.KGEEJ2016-09-15
J011074101000N.A.DENTAURUM GmbH & Co.KGEEJ2016-09-15
J011074201000N.A.DENTAURUM GmbH & Co.KGEEJ2016-09-15