FDA.reportPublic FDA data

Noninium®

Primary DI
J011621040000
Brand
Noninium®
Company
DENTAURUM GmbH & Co.KG
Model
621-040-00
Device description
Noninium® standard labial arches, Length 40 mm
Published
2026-09-04
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
J011621040000PrimaryHIBCC0
J011621040001Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic wireA thread or slender rod of metal (e.g., stainless steel, precious metal) incorporated into an orthodontic appliance, typically as part of an orthodontic appliance system. It is available in various dimensions and grades, and is used to exert pressure on teeth in order to alter their position. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011302150000tomas®302-150-002026-09-04
J011302250000tomas®302-250-002026-09-04
J011520120000Noninium®520-120-002026-09-04
J011621404000Noninium®621-404-002026-09-04
J011621407000Noninium®621-407-002026-09-04
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J011621404000Noninium®DENTAURUM GmbH & Co.KGEHP2026-09-04
J011621407000Noninium®DENTAURUM GmbH & Co.KGEHP2026-09-04
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