FDA.reportPublic FDA data

N.A.

Primary DI
J011312106000
Brand
N.A.
Company
DENTAURUM GmbH & Co.KG
Model
312-106-00
Device description
Strengtheners twisted, rolled flat, 1.80 x 0.80 mm, 10 m
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
ECNCLAMP, WIRE, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECNClamp, Wire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011312106000PrimaryHIBCC0

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
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
J011250024200ceraMotion®250-024-202016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456221730JMUJMU DENTAL, INCECN2026-05-11
00840456221747JMUJMU DENTAL, INCECN2026-05-11
006522210993343M™ Unitek™ Intraoral Attachments3M UNITEK CORPORATIONECN2026-05-07
00190746203770Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203787Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203794Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203800Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203817Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203824Weldable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
00190746203831Bondable CleatAMERICAN ORTHODONTICS CORPORATIONECN2026-04-21
10371347023203Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023210Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023227Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023234Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023241Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023258Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023265Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023272Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
10371347023289Advance Dental ProductsThe Atlanta Dental Supply CompanyECN2026-04-14
07908611211644CRIMPABLE BALL HOOK - UNIVERSAL - 2.7MM - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611211651CRIMPABLE BALL HOOK - UNIVERSAL - 4,0MM - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611211668BUTTON WITH LONG HOOK FOR BONDING - LEFT - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212603BUTTON WITH LONG HOOK FOR BONDING - RIGHT - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212634ORTHODONTIC SPUR - 50UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212665ORTHODONTIC BITE TURBO - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611212672LINGUAL BUTTON PERFORATED BASE FOR BONDING - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611213815BUTTON WITH CAPLIN HOOK FOR BONDING - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611214928LONG CRIMPABLE HOOK - RECTANGULAR - LEFT - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
07908611214935LONG CRIMPABLE HOOK - RECTANGULAR - RIGHT - 5UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDAECN2026-01-12
00190707124267Ortho Technology®Ortho Organizers, Inc.ECN2025-10-17