TruKLear C715-1413
GUDID EFORC7151413
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.
Forestadent Bernhard Förster GmbH
Orthodontic bracket, ceramic| Primary Device ID | EFORC7151413 |
| NIH Device Record Key | 37f7dbd1-6a30-408f-9400-92b5d4bdc841 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TruKLear |
| Version Model Number | C715-1413 |
| Catalog Number | C715-1413 |
| Company DUNS | 316074384 |
| Company Name | Forestadent Bernhard Förster GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Height | 0.018 Inch |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EFORC7151413 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K141104
FDA Product Code
| NJM | Bracket, Ceramic, Orthodontic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-10-31 |
| Device Publish Date | 2016-10-28 |
On-Brand Devices [TruKLear ]
| EFORC7151613 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7151611 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7151513 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7151511 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7151413 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7151411 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7150513 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7150511 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7150503 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7150501 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7150413 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7150411 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7150403 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7150401 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7150313 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7150311 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7150203 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7150201 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7150103 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7150101 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7141613 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7141611 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7141513 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7141511 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7141413 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7141411 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7141203 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7141201 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7140513 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7140511 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7140503 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7140501 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7140413 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7140411 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7140403 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7140401 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7140313 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7140311 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7140203 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7140201 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7140103 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7140101 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7131613 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7131611 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7131513 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7131511 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7131413 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7131411 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7130513 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
| EFORC7130511 | The Device is intended for orthodontic movement of teeth. It is used temporarily and is removed |
Trademark Results [TruKLear]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUKLEAR 79150646 4762455 Live/Registered |
Bernhard Förster GmbH 2014-02-27 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.