clearcorrect.comClearCorrect System
ClearCorrect, LLC
ClearCorrect , LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3007130440 | 3007130440 | ClearCorrect , LLC | 1 | N | 2026-01-01 | 21 Cypress Blvd Ste 1010 Round Rock TX US 78665 |
| 3007130440 | 3007130440 | CLEARCORRECT LLC | 1 | N | 2020-04-25 | 21 Cypress Blvd Ste 1010 Round Rock TX US 78665 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| D865REF0001 | ClearCorrect System - The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner. | 888-331-3323 | support@clearcorrect.com |
| D865REF0002 | ClearCorrect System - Engager template device accessory for use with the ClearCorrect System. | (888) 331-3323 | support@clearcorrect.com |
| D865REF00051 | ClearCorrect System - The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner. | 888-331-3323 | support@clearcorrect.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 297267 | 1557857507 | K210320 | ClearCorrect System | NXC | 2021-08-06 |
| 91448 | 1989332340 | K113618 | CLEARCORRECT SYSTEM | NXC | 2012-03-19 |
| 297267 | 2068898593 | K113618 | CLEARCORRECT SYSTEM | NXC | 2012-03-19 |
| 91448 | 1705683363 | K082556 | CLEARCORRECT | NXC | 2009-02-06 |
| 297267 | 1413477030 | ||||
| 297267 | 1826226795 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NXC | 4 | 2021-08-06 |
PMN#
ClearCorrect System
ClearCorrect LLC
CLEARCORRECT SYSTEM
CLEARCORRECT, INC.
CLEARCORRECT
CLEARCORRECT, INC.
GUDID#
ClearCorrect System Engager Template - Accessory device of the ClearCorrect System clear aligner system. Device is used by the clinician to add composite features to the teeth, referred to as Engagers. The Engagers have orthodontic force applied to them by the Aligners of the ClearCorrect System. The use of Engagers facilitates Aligner retention on the teeth and also facilities certain tooth movements that are difficult to achieve by applying force to the tooth surface itself. The Engager Template is used by the clinician in the clinical setting. The device is single use and disposed of after use. Duration of use is less than one hour.
2024-02-02
ClearCorrect System - The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner.
2023-08-25
ClearCorrect System - The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic and functions to hold the teeth in their new positions after orthodontic tooth movement is achieved. During this phase of treatment, the fundamental function of the appliance is to maintain tooth position rather than provided continuous force application.
2023-08-25
ClearCorrect System - The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite resin in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner
2023-08-25
ClearCorrect System - Engager template device accessory for use with the ClearCorrect System.
2023-08-25
ClearCorrect System - Engager template device accessory for use with the ClearCorrect System.
2019-04-08
ClearCorrect System - The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner.
2019-04-08
ClearCorrect System - The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner.
2020-07-23
ClearCorrect System - The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic and functions to hold the teeth in their new positions after orthodontic tooth movement is achieved. During this phase of treatment, the fundamental function of the appliance is to maintain tooth position rather than provided continuous force application.
2020-07-23
ClearCorrect System - The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite resin in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner
2020-07-23
ClearCorrect System - Engager template device accessory for use with the ClearCorrect System.
2020-07-23
ClearCorrect System - The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively reposition teeth. Corrective force to straighten teeth is delivered via minor changes into a position in each subsequent aligner.
2020-07-23