FDA.reportPublic FDA data

rematitan®

Primary DI
J011768107010
Brand
rematitan®
Company
DENTAURUM GmbH & Co.KG
Model
768-107-01
Device description
rematitan® “LITE”, lower, 19 x 25 (50 pcs.)
Published
2019-08-21
Public version status
New
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
DZCWIRE, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K935140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K935140000DENTAURUM STEEL LIGATURE WIRESDentauraum, Inc.1994-02-04DZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011768107010PrimaryHIBCC0
J011768107011Unit of UseHIBCC0

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
50
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011102620600remanium®102-620-602026-11-04
J011850124000N.A.850-124-002016-09-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190746202841Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202858Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202865Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202872Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202889Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202896Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202902Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202919Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202926Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202933Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202940Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202957Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202964Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202971Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202988Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746202995Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203008Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203015Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203022Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203039Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203046Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203053Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203060Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203077Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203084Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203091Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203107Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203114Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203121Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29
00190746203138Tanzo TriForceAMERICAN ORTHODONTICS CORPORATIONDZC2026-10-29