Identity
- Trade Name
- ClearCorrect System Aligner (Multi-layer) EUDAMEDClearCorrect System FDA UDI
- Generic Name
- Orthodontic progressive aligner FDA UDI
- Device Name
- ClearCorrect Orthodontic Appliance EUDAMEDThe 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 FDA UDI
- Model / Reference
- REF03 EUDAMEDAligner (Multi-layer) FDA UDI
- Description
- 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 FDA UDI
Identifiers
- Catalog Number
- REF03 FDA UDI
- Primary DI / UDI-DI
- D865REF03001 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D865CCOrthoAppliance4G EUDAMED
- FDA Product Code
- NXC FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic progressive aligner FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic progressive aligner
ClearCorrect System by ClearCorrect Operating LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic progressive aligner.
- Risas Reveal® — Ortho Organizers, Inc. · Class II
- Reveal® Aligners — Ortho Organizers, Inc. · Class II
- SLX® Clear Aligners — Ortho Organizers, Inc. · Class II
- Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II
- 3M™ Clarity™ — 3M UNITEK CORPORATION · Class II
- Risas Reveal Aligners — Ortho Organizers, Inc. · Class II
- Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II
- Reveal® Clear Aligners — Ortho Organizers, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ClearCorrect Operating LLC
Sources (2)
- FDA UDI 91388a5a-78bf-4e45-b320-dda5fb0dab3d 35 fields · synced Aug 3, 2026
- EUDAMED 321828cc-6010-43aa-ac35-a65a58511e36 61 fields · synced Aug 3, 2026