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Invisalign Palatal Holder
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 9032Model Invisalign Palatal Expander System
Identity
- Trade Name
- Invisalign Palatal Holder EUDAMEDFDA UDI
- Generic Name
- Orthodontic retainer FDA UDI
- Device Name
- Invisalign Palatal Expander System EUDAMEDPalatal Holder FDA UDI
- Model / Reference
- Invisalign Palatal Expander System EUDAMED9032 EUDAMEDFDA UDI
- Description
- Palatal Holder FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063021384 EUDAMEDFDA UDI
- Basic UDI-DI
- 081606302IPESystem6S EUDAMED
- 510(k) Number
- K232887 FDA UDI
- FDA Product Code
- NXC FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic retainer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.5470 FDA UDI
- Market of Registration
- Netherlands 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Invisalign Palatal Holder by Align Technology, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 081606302IPESystem6S | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Align Technology Inc.
- EUDAMED SRN
- US-MF-000000744
- Authorised Representative
- Align Technology B.V. NL-AR-000000061
Sources (2)
- EUDAMED 0dd79744-f3de-4f2d-a52e-b5ba75d237d4 61 fields · synced Jun 19, 2026
- FDA UDI c50a131c-72d0-4406-a6a1-45497b50aba9 34 fields · synced May 30, 2026