TruKlear®
GUDID EFORC71505131
TruKlear Bracket McLaugh/Benn/Trev. .018" max. 5 right w. hook
Forestadent Bernhard Förster GmbH
Orthodontic bracket, ceramic| Primary Device ID | EFORC71505131 |
| NIH Device Record Key | 94dc06fe-0b08-4bbe-b431-d65ca58bc6bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TruKlear® |
| Version Model Number | C715-0513 |
| 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 | true |
| 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 |
Customer Support Contacts
| Phone | +4972314590 |
| regulatory@forestadent.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | EFORC71505131 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-08-23 |
| Device Publish Date | 2019-08-15 |
On-Brand Devices [TruKlear®]
| EFORC70730151 | TruKlear Starterkit McLaugh/Benn/Trev. .022" 3 cases |
| EFORC70730141 | TruKlear Starterkit McLaugh/Benn/Trev. .018" 3 cases |
| EFORC70730131 | TruKlear Starterkit Roth .022" 3 cases |
| EFORC70730121 | TruKlear Starterkit Roth .018" 3 cases |
| EFORC71516130101 | TruKlear Bracket McLaugh/Benn/Trev. .018" mand. 5 right w. hook |
| EFORC71516130051 | TruKlear Bracket McLaugh/Benn/Trev. .018" mand. 5 right w. hook |
| EFORC71516110101 | TruKlear Bracket McLaugh/Benn/Trev. .022" mand. 5 right w. hook |
| EFORC71516110051 | TruKlear Bracket McLaugh/Benn/Trev. .022" mand. 5 right w. hook |
| EFORC71515130101 | TruKlear Bracket McLaugh/Benn/Trev. .018" mand. 4 right w. hook |
| EFORC71515130051 | TruKlear Bracket McLaugh/Benn/Trev. .018" mand. 4 right w. hook |
| EFORC71515110101 | TruKlear Bracket McLaugh/Benn/Trev. .022" mand. 4 right w. hook |
| EFORC71515110051 | TruKlear Bracket McLaugh/Benn/Trev. .022" mand. 4 right w. hook |
| EFORC71514130101 | TruKlear Bracket McLaugh/Benn/Trev. .018" mand. 3 right w. hook |
| EFORC71514130051 | TruKlear Bracket McLaugh/Benn/Trev. .018" mand. 3 right w. hook |
| EFORC71514110101 | TruKlear Bracket McLaugh/Benn/Trev. .022" mand. 3 right w. hook |
| EFORC71514110051 | TruKlear Bracket McLaugh/Benn/Trev. .022" mand. 3 right w. hook |
| EFORC71505130101 | TruKlear Bracket McLaugh/Benn/Trev. .018" max. 5 right w. hook |
| EFORC71505130051 | TruKlear Bracket McLaugh/Benn/Trev. .018" max. 5 right w. hook |
| EFORC71505110101 | TruKlear Bracket McLaugh/Benn/Trev. .022" max. 5 right w. hook |
| EFORC71505110051 | TruKlear Bracket McLaugh/Benn/Trev. .022" max. 5 right w. hook |
| EFORC71505030101 | TruKlear Bracket McLaugh/Benn/Trev. .018" max. 5 right |
| EFORC71505030051 | TruKlear Bracket McLaugh/Benn/Trev. .018" max. 5 right |
| EFORC71505010101 | TruKlear Bracket McLaugh/Benn/Trev. .022" max. 5 right |
| EFORC71505010051 | TruKlear Bracket McLaugh/Benn/Trev. .022" max. 5 right |
| EFORC71504130101 | TruKlear Bracket McLaugh/Benn/Trev. .018" max. 4 right w. hook |
| EFORC71504130051 | TruKlear Bracket McLaugh/Benn/Trev. .018" max. 4 right w. hook |
| EFORC71504110101 | TruKlear Bracket McLaugh/Benn/Trev. .022" max. 4 right w. hook |
| EFORC71504110051 | TruKlear Bracket McLaugh/Benn/Trev. .022" max. 4 right w. hook |
| EFORC71504030101 | TruKlear Bracket McLaugh/Benn/Trev. .018" max. 4 right |
| EFORC71504030051 | TruKlear Bracket McLaugh/Benn/Trev. .018" max. 4 right |
| EFORC71504010101 | TruKlear Bracket McLaugh/Benn/Trev. .022" max. 4 right |
| EFORC71504010051 | TruKlear Bracket McLaugh/Benn/Trev. .022" max. 4 right |
| EFORC71503130101 | TruKlear Bracket McLaugh/Benn/Trev. .018" max. 3 right w. hook |
| EFORC71503130051 | TruKlear Bracket McLaugh/Benn/Trev. .018" max. 3 right w. hook |
| EFORC71503110101 | TruKlear Bracket McLaugh/Benn/Trev. .022" max. 3 right w. hook |
| EFORC71503110051 | TruKlear Bracket McLaugh/Benn/Trev. .022" max. 3 right w. hook |
| EFORC71502030101 | TruKlear Bracket McLaugh/Benn/Trev. .018" max. 2 right |
| EFORC71502030051 | TruKlear Bracket McLaugh/Benn/Trev. .018" max. 2 right |
| EFORC71502010101 | TruKlear Bracket McLaugh/Benn/Trev. .022" max. 2 right |
| EFORC71502010051 | TruKlear Bracket McLaugh/Benn/Trev. .022" max. 2 right |
| EFORC71501030101 | TruKlear Bracket McLaugh/Benn/Trev. .018" max. 1 right |
| EFORC71501030051 | TruKlear Bracket McLaugh/Benn/Trev. .018" max. 1 right |
| EFORC71501010101 | TruKlear Bracket McLaugh/Benn/Trev. .022" max. 1 right |
| EFORC71501010051 | TruKlear Bracket McLaugh/Benn/Trev. .022" max. 1 right |
| EFORC71416130101 | TruKlear Bracket McLaugh/Benn/Trev. .018" mand. 5 left w. hook |
| EFORC71416130051 | TruKlear Bracket McLaugh/Benn/Trev. .018" mand. 5 left w. hook |
| EFORC71416110101 | TruKlear Bracket McLaugh/Benn/Trev. .022" mand. 5 left w. hook |
| EFORC71416110051 | TruKlear Bracket McLaugh/Benn/Trev. .022" mand. 5 left w. hook |
| EFORC71415130101 | TruKlear Bracket McLaugh/Benn/Trev. .018" mand. 4 left w. hook |
| EFORC71415130051 | TruKlear Bracket McLaugh/Benn/Trev. .018" mand. 4 left w. hook |
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.