FDA.reportPublic FDA data

N.A.

Primary DI
J011074000000
Brand
N.A.
Company
DENTAURUM GmbH & Co.KG
Model
074-000-00
Device description
Oral screen “Ulmer Modell”, Mini/Size 1
Published
2016-09-15
Public version status
Update
Distribution status
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
J011074000000PrimaryHIBCC0

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

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
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
J011262411100Carmen®262-411-102016-09-15
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
00840326403051The Orthodontic StoreYoung Innovations, Inc.EEJ2022-11-24
10840326403058The Orthodontic StoreYoung Innovations, Inc.EEJ2022-11-24
J01174206000N.A.DENTAURUM GmbH & Co.KGEEJ2018-12-06
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
J011074200000N.A.DENTAURUM GmbH & Co.KGEEJ2016-09-15
J011074201000N.A.DENTAURUM GmbH & Co.KGEEJ2016-09-15