FDA.reportPublic FDA data

TruKlear

Primary DI
EFORC7131513
Brand
TruKlear
Company
Forestadent Bernhard Förster GmbH
Model
C713-1513
Catalog number
C713-1513
Device description
The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.
Published
2016-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NJMBracket, Ceramic, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NJMBracket, Ceramic, OrthodonticDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141104000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141104000TRUKLEAR BRACKETAjw Technology Consultants, Inc.2014-06-25NJM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EFORC7131513PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, ceramicA ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0.018Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
316074384
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EFOR4080105Track A1-408-01052025-07-04
EFOR4080106Track A1-408-01062025-07-04
EFOR4080108Track A1-408-01082025-07-04
EFOR4080110Track A1-408-01102025-07-04
EFOR4080115Track A1-408-01152025-07-04
EFOR4080120Track A1-408-01202025-07-04
EFOR4080220Track B1-408-02202025-07-04
EFOR4080515Track E1-408-05152025-07-04
EFOR4080520Track E1-408-05202025-07-04
EFOR4080530Track E1-408-05302025-07-04
EFOR5011845Special instrument for opening of BioQui-501-18452024-11-29
EFOR5011846Two pronged probe for BioQuick Brackets-501-18462024-11-30
EFOR4080610Track bleach-408-06102023-08-11
EFOR1101A23061OrthoEasy®1101A23062019-08-15
EFOR1101A23081OrthoEasy®1101A23082019-08-15
EFOR1101A23101OrthoEasy®1101A23102019-08-15
EFOR1201A23081OrthoEasy®1201A23082019-08-15
EFOR4080610001Track bleach-408-06102023-08-11
EFOR31210011N.A.-312-10012019-09-24
EFOR31210021N.A.-312-10022019-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611210067PROMO KIT ICERAM-P ROTH 0.022ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDANJM2024-04-16
08800046016025VAR-18-301GNI Co.,LtdNJM2022-12-14
08800046016032VAR-18-331GNI Co.,LtdNJM2022-12-14
08800046016049VAR-18-051GNI Co.,LtdNJM2022-12-14
08800046016056VAR-18-501GNI Co.,LtdNJM2022-12-14
08800046016063VAR-18-551GNI Co.,LtdNJM2022-12-14
08800046016070VAR-18-053GNI Co.,LtdNJM2022-12-14
08800046016087VAR-18-503GNI Co.,LtdNJM2022-12-14
08800046016094VAR-18-553GNI Co.,LtdNJM2022-12-14
08800046016100VAR-22-031GNI Co.,LtdNJM2022-12-14
08800046016117VAR-22-301GNI Co.,LtdNJM2022-12-14
08800046016124VAR-22-331GNI Co.,LtdNJM2022-12-14
08800046016131VAR-22-051GNI Co.,LtdNJM2022-12-14
08800046016148VAR-22-501GNI Co.,LtdNJM2022-12-14
08800046016155VAR-22-551GNI Co.,LtdNJM2022-12-14
08800046016162VAR-22-053GNI Co.,LtdNJM2022-12-14
08800046016179VAR-22-503GNI Co.,LtdNJM2022-12-14
08800046016193VAM-18-031GNI Co.,LtdNJM2022-12-14
08800046016209VAM-18-301GNI Co.,LtdNJM2022-12-14
08800046016216VAM-18-331GNI Co.,LtdNJM2022-12-14
08800046016223VAM-18-051GNI Co.,LtdNJM2022-12-14
08800046016230VAM-18-501GNI Co.,LtdNJM2022-12-14
08800046016247VAM-18-551GNI Co.,LtdNJM2022-12-14
08800046016254VAM-18-053GNI Co.,LtdNJM2022-12-14
08800046016261VAM-18-503GNI Co.,LtdNJM2022-12-14
08800046016278VAM-18-553GNI Co.,LtdNJM2022-12-14
08800046016285VAM-22-031GNI Co.,LtdNJM2022-12-14
08800046016292VAM-22-301GNI Co.,LtdNJM2022-12-14
08800046016308VAM-22-331GNI Co.,LtdNJM2022-12-14
08800046016315VAM-22-051GNI Co.,LtdNJM2022-12-14