Identity
- Trade Name
- SureCure FDA UDI
- Generic Name
- Orthodontic progressive aligner FDA UDI
- Device Name
- Orthodontic appliance system, progressive FDA PT: HJDC FDA UDI
- Model / Reference
- Aligners FDA UDI
- Description
- Orthodontic appliance system, progressive FDA PT: HJDC FDA UDI
Identifiers
- Primary DI / UDI-DI
- D918SCA0 FDA UDI
- 510(k) Number
- K182329 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthodontic progressive aligner
SureCure by Digital Orthodontic Care — Class II — FDA UDI — listed in FDA GUDID — 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
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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
Cleared under the same submission
K182329 also covers:
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
- Digital Orthodontic Care
Sources (1)
- FDA UDI fc0b0d96-ad4d-404a-9fca-ae3d5142c53d 34 fields · synced Jun 8, 2026