FDA.reportPublic FDA data

Noninium®

Primary DI
J011621037000
Brand
Noninium®
Company
DENTAURUM GmbH & Co.KG
Model
621-037-00
Device description
Noninium® standard labial arches, Length 37 mm
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
EHPCLASP, PREFORMED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHPClasp, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011621037000PrimaryHIBCC0
J011621037001Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic teeth positioner, preformedA prefabricated dental device, typically made of plastic, that is an impression of a perfected bite used to prevent a patient's teeth from shifting position, or to move teeth to a final position, after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position. This is a 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
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J01810171J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810172J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810181J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810182J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810191J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810192J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810211J-Clasp oblique Scheu-Dental GmbHEHP2024-11-19
J01810212J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01810221J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01810222J-Clasp oblique Scheu-Dental GmbHEHP2024-11-19
J01810231JM-ClaspScheu-Dental GmbHEHP2024-11-19
J01810261T-ClaspScheu-Dental GmbHEHP2024-11-19
J01810271T-ClaspScheu-Dental GmbHEHP2024-11-19
J01810471J-ClaspScheu-Dental GmbHEHP2024-11-19
J01810481J-Clasp obliqueScheu-Dental GmbHEHP2024-11-19
J01820481SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820482SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820491SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820492SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820493SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820501SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820502SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820503SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820511SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820512SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820513SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820521SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820522SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820531SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19
J01820532SCHEU-AnchorScheu-Dental GmbHEHP2024-11-19