| Primary Device ID | D865REF06001 |
| NIH Device Record Key | 902061e5-4e12-4dd0-ba43-3c7d98dd393a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClearCorrect System Engager Template |
| Version Model Number | REF06 |
| Catalog Number | REF06 |
| Company DUNS | 016449078 |
| Company Name | Clearcorrect Operating, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| 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 |
| D865REF06001 - ClearCorrect System Engager Template | 2024-02-12Accessory 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. |
| D865REF06001 - ClearCorrect System Engager Template | 2024-02-12 Accessory device of the ClearCorrect System clear aligner system. Device is used by the clinician to add composite features to |
| D865REF02001 - ClearCorrect System | 2023-09-04 Engager template device accessory for use with the ClearCorrect System. |
| D865REF03001 - ClearCorrect System | 2023-09-04 The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite resin in a sequential series to |
| D865REF04001 - ClearCorrect System | 2023-09-04 The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic and functions to hold the teeth i |
| D865REF05001 - ClearCorrect System | 2023-09-04 The ClearCorrect device is fabricated of clear thin thermoformed polyurethane plastic in a sequential series to progressively re |
| D865REF00011 - ClearCorrect System | 2020-07-31 The ClearCorrect device is fabricated of clear thin thermoformed polyeurethane plastic in a sequential series to progressively r |
| D865REF00021 - ClearCorrect System | 2020-07-31 Engager template device accessory for use with the ClearCorrect System. |
| D865REF00031 - ClearCorrect System | 2020-07-31 The ClearCorrect device is fabricated of thin thermoplastic polyurethane/co-polyester composite resin in a sequential series to |