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Invisalign Palatal Expander
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 9031Model Invisalign Palatal Expander System510(k) K252931
Identity
- Trade Name
- Invisalign Palatal Expander EUDAMEDFDA UDI
- Generic Name
- Orthodontic palate expander/teeth aligner, self-removable FDA UDI
- Device Name
- Invisalign Palatal Expander System EUDAMEDPalatal Expanders FDA UDI
- Model / Reference
- Invisalign Palatal Expander System EUDAMED9031 EUDAMEDFDA UDI
- Description
- Palatal Expanders FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063021391 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 palate expander/teeth aligner, self-removable 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 Expander by Align Technology, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252931 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K232887 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 081606302IPESystem6S | Class IIa | Active |
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Manufacturer
- Manufacturer
- Align Technology Inc.
- EUDAMED SRN
- US-MF-000000744
- FDA Applicant
- Align Technology, Inc.
- Authorised Representative
- Align Technology B.V. NL-AR-000000061
Sources (3)
- EUDAMED ed0a462f-dfba-45ad-9962-dca7ef2e9a01 85 fields · synced Jun 18, 2026
- FDA UDI f94ff2cd-2e9c-4095-8a65-a7a8f2f6ce13 34 fields · synced May 29, 2026
- FDA 510(k) K252931 1 fields · synced May 18, 2026