Identity
- Trade Name
- ClearCorrect System Retainer EUDAMEDClearCorrect System FDA UDI
- Generic Name
- Orthodontic retainer FDA UDI
- Device Name
- ClearCorrect Orthodontic Appliance EUDAMEDThe ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic and functions to hold the teeth in their new positions after orthodontic tooth movement is achieved. During this phase of treatment, the fundamental function of the appliance is to maintain tooth position rather than provided continuous force application. FDA UDI
- Model / Reference
- REF04 EUDAMEDRetainer FDA UDI
- Description
- The ClearCorrect retainer device is fabricated of clear thin thermoformed polyurethane plastic and functions to hold the teeth in their new positions after orthodontic tooth movement is achieved. During this phase of treatment, the fundamental function of the appliance is to maintain tooth position rather than provided continuous force application. FDA UDI
Identifiers
- Catalog Number
- REF04 FDA UDI
- Primary DI / UDI-DI
- D865REF04001 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D865CCOrthoAppliance4G EUDAMED
- FDA Product Code
- KMY FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic retainer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.5525 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
Yes
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 retainer
ClearCorrect System by ClearCorrect Operating LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Orthodontic retainer.
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- Orthodontic Wires and Springs — MEM Dental Technology Co., Ltd · Class IIa
- Stainless Steel Spring — American Orthodontics · Class IIa
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 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 e74b1e9b-c345-47fd-ae44-6187649242e5 35 fields · synced Jun 18, 2026
- EUDAMED 71baef75-2ac2-4864-8e9e-fd260ac89139 61 fields · synced Jun 18, 2026