Identity
- Trade Name
- TRIOCLEAR System FDA UDI
- Generic Name
- Orthodontic progressive aligner FDA UDI
- Device Name
- The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLEAR is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing sets of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. FDA UDI
- Model / Reference
- 013 FDA UDI
- Description
- The TRIOCLEAR System is a removable, non-sterile device intended for single patient use. TRIOCLEAR is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing sets of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972677870139 FDA UDI
- FDA Product Code
- NXC FDA UDI
- GMDN Term
- Orthodontic progressive aligner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic progressive aligner
TRIOCLEAR System by Modern Dental Laboratory (DG) Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthodontic progressive aligner.
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- 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 (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 II | Pending data |
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Manufacturer
- Manufacturer
- Modern Dental Laboratory (DG) Co., Ltd.
Sources (1)
- FDA UDI a4d8ef4d-31a1-45da-a181-d641c341ce5b 33 fields · synced Jun 1, 2026