Identity
- Trade Name
- ClearCorrect System FDA UDI
- Generic Name
- Orthodontic resin positioning tray FDA UDI
- Device Name
- Engager template device accessory for use with the ClearCorrect System. FDA UDI
- Model / Reference
- Engager Template FDA UDI
- Description
- Engager template device accessory for use with the ClearCorrect System. FDA UDI
Identifiers
- Catalog Number
- REF02 FDA UDI
- Primary DI / UDI-DI
- D865REF02001 FDA UDI
- FDA Product Code
- QJJ FDA UDI
- GMDN Term
- Orthodontic resin positioning tray FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Orthodontic resin positioning tray
ClearCorrect System by ClearCorrect Operating LLC — Class I — FDA UDI — listed in FDA GUDID — 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 Engager Template — ClearCorrect Operating LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ClearCorrect Operating LLC
Sources (1)
- FDA UDI 0f521158-0e01-4e18-8c7f-552e9ef917b2 35 fields · synced May 30, 2026