ClearCorrect System Engager Template
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- ClearCorrect System Engager Template EUDAMEDFDA UDI
- Generic Name
- Orthodontic resin positioning tray FDA UDI
- Device Name
- ClearCorrect System Accessory EUDAMEDAccessory 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. FDA UDI
- Model / Reference
- REF06 EUDAMEDFDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- REF06 FDA UDI
- Primary DI / UDI-DI
- D865REF06001 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D865CCOrthoAccessoryV4 EUDAMED
- FDA Product Code
- QJJ FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic resin positioning tray FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Orthodontic resin positioning tray
ClearCorrect System Engager Template by ClearCorrect Operating LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic resin positioning tray.
- Attachment Template — Align Technology, Inc. · Class II
- Unismile Clear Aligner — VITANG TECHNOLOGY LLC · Class II
- ClearCorrect System — ClearCorrect Operating LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ClearCorrect Operating LLC
Sources (2)
- FDA UDI 902061e5-4e12-4dd0-ba43-3c7d98dd393a 35 fields · synced Jul 16, 2026
- EUDAMED 37b0a1e6-2720-4a4b-b768-e750df9e7c27 61 fields · synced Jul 16, 2026