FDA.reportPublic FDA data

rematitan®

Primary DI
J011528044000
Brand
rematitan®
Company
DENTAURUM GmbH & Co.KG
Model
528-044-00
Device description
Pure titanium straight wire, rolled, 0.25 x 3.0 mm, Length 100 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
DZCWIRE, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011528044000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental brazing alloyA mixture of metals, usually in the form of a thin rod, used to braze cast dental restorations. It is a fusible alloy used to join less fusible materials (e.g., other metals, metal wires) through the application of high-temperature heat to the metal components to be joined; the brazing metal melts around the joint to create the fusion. The brazing process operates at higher temperatures than soldering. After application, this device cannot be reused.

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
J011250321030ceraMotion®250-321-032026-10-23
J011250322030ceraMotion®250-322-032026-10-23
J011250337030ceraMotion®250-337-032026-10-23
J011250338030ceraMotion®250-338-032026-10-23
J011741049000N.A.741-049-002016-09-15
J011302112000tomas®302-112-002026-09-30
J011302114000tomas®302-114-002026-09-30
J011302212000tomas®302-212-002026-09-30
J011302214000tomas®302-214-002026-09-30
J011250301010ceraMotion®250-301-012026-09-25
J011250306010ceraMotion®250-306-012026-09-25
J011254012040ceraMotion®254-012-042026-09-25
J011254014040ceraMotion®254-014-042026-09-25
J011302150000tomas®302-150-002026-09-04
J011302250000tomas®302-250-002026-09-04
J011520120000Noninium®520-120-002026-09-04
J011621040000Noninium®621-040-002026-09-04
J011621404000Noninium®621-404-002026-09-04
J011621407000Noninium®621-407-002026-09-04
J011130131000N.A.130-131-002020-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190707195014Retainer WireOrtho Organizers, Inc.DZC2026-10-20
05056389639589Pg SupplyPg Supply, Inc.DZC2026-09-28
05056389639596Pg SupplyPg Supply, Inc.DZC2026-09-28
05056389639602Pg SupplyPg Supply, Inc.DZC2026-09-28
05056389639619Pg SupplyPg Supply, Inc.DZC2026-09-28
J011520120000Noninium®DENTAURUM GmbH & Co.KGDZC2026-09-04
00840456209882JMUJMU DENTAL, INCDZC2026-06-25
00840456209899JMUJMU DENTAL, INCDZC2026-06-25
00840456209905JMUJMU DENTAL, INCDZC2026-06-25
00840456209912JMUJMU DENTAL, INCDZC2026-06-25
00840456209929JMUJMU DENTAL, INCDZC2026-06-25
00840456209936JMUJMU DENTAL, INCDZC2026-06-25
00840456209943JMUJMU DENTAL, INCDZC2026-06-25
00840456209950JMUJMU DENTAL, INCDZC2026-06-25
00840456209967JMUJMU DENTAL, INCDZC2026-06-25
00840456209974JMUJMU DENTAL, INCDZC2026-06-25
00840456209981JMUJMU DENTAL, INCDZC2026-06-25
00840456209998JMUJMU DENTAL, INCDZC2026-06-25
00840456210000JMUJMU DENTAL, INCDZC2026-06-25
00840456210017JMUJMU DENTAL, INCDZC2026-06-25
00840456210024JMUJMU DENTAL, INCDZC2026-06-25
00840456210031JMUJMU DENTAL, INCDZC2026-06-25
00840456210048JMUJMU DENTAL, INCDZC2026-06-25
00840456210055JMUJMU DENTAL, INCDZC2026-06-25
00840456210062JMUJMU DENTAL, INCDZC2026-06-25
00840456210079JMUJMU DENTAL, INCDZC2026-06-25
00840456210086JMUJMU DENTAL, INCDZC2026-06-25
00840456210093JMUJMU DENTAL, INCDZC2026-06-25
00840456210109JMUJMU DENTAL, INCDZC2026-06-25
00840456210116JMUJMU DENTAL, INCDZC2026-06-25