Invisalign System – Lite
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- Invisalign System – Lite EUDAMEDInvisalign System - Lite FDA UDI
- Generic Name
- Orthodontic progressive aligner FDA UDI
- Device Name
- Invisalign System EUDAMEDSequential Aligners FDA UDI
- Model / Reference
- Invisalign System EUDAMED9002 EUDAMEDFDA UDI
- Description
- Sequential Aligners FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816063020202 EUDAMEDFDA UDI
- Basic UDI-DI
- 081606302InvisalignMH EUDAMED
- FDA Product Code
- NXC FDA UDI
- EMDN Code
- Q010499 ORTHODONTIC DEVICES - OTHER EUDAMED
- GMDN Term
- Orthodontic progressive aligner 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
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
The Invisalign System – Lite is a clear aligner orthodontic device (Nomenclature Code: Q010499) designed for the gradual correction of dental alignment. Classified as a Class IIa medical device, it applies controlled force to teeth through a series of removable, custom-fitted aligners to achieve incremental repositioning over time.
Supplied as a non-sterile, non-reusable system (Reference: 9002), the Invisalign System – Lite is intended for use in dental practices under professional supervision. Each aligner set is uniquely identified by a Basic UDI (081606302InvisalignMH) and adheres to regulatory standards including FDA 510K clearance and MDR compliance. Storage and handling follow manufacturer guidelines to maintain integrity prior to clinical use.
Frequently asked questions
What is the Invisalign System – Lite primarily used for in clinical practice?
The Invisalign System – Lite is designed for the gradual correction of dental alignment, applying controlled force to teeth through a series of removable, custom-fitted clear aligners. It is intended for use in dental practices under professional supervision to achieve incremental repositioning of teeth over time.
Is the Invisalign System – Lite reusable or single-use, and how should it be handled?
The Invisalign System – Lite is a non-reusable, single-use device (Reference: 9002). It is supplied as a non-sterile system, so handling must follow manufacturer guidelines to maintain integrity before clinical use. Sterilization or reprocessing is not applicable.
How can I identify a specific set of aligners from the Invisalign System – Lite?
Each aligner set in the Invisalign System – Lite is uniquely identified by a Basic UDI: **081606302InvisalignMH**. This UDI helps track and verify the specific set for regulatory and clinical purposes.
What regulatory pathways does the Invisalign System – Lite follow?
The Invisalign System – Lite complies with FDA 510K clearance and MDR (Medical Device Regulation) standards. It is classified as a Class IIa medical device under nomenclature code **Q010499**, ensuring it meets stringent regulatory requirements for orthodontic aligners.
Does the Invisalign System – Lite contain any substances that could cause allergic reactions?
The device does not contain latex (Latex: 0) or animal/human tissues (Animal_Tissues: 0, Human_Tissues: 0), nor is it a medicinal product or implantable. However, patients should still be screened for potential sensitivities to aligner materials as part of standard clinical practice.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Wie funktioniert das Invisalign System | Invisalign Zahnspangen, Invisalign®️ Anwendersuche| Einen zertifizierten Invisalign …, Invisalign: Kosten, Ablauf und Vorteile - CHECK24, Invisalign® Clear Aligners & Teeth Straightening | Invisalign.com, Invisalign (Beratung), Bad Reichenhall - jameda
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143630 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K252380 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K981095 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K241412 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K081960 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K220287 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 081606302InvisalignMH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Align Technology Inc.
- EUDAMED SRN
- US-MF-000000744
- Authorised Representative
- Align Technology B.V. NL-AR-000000061
Sources (3)
- EUDAMED 31851d73-46b9-42da-a4a1-5c1867cf774f 61 fields · synced Sep 18, 2026
- FDA UDI 35ee4f3c-63fe-4790-b2a5-3c95e08368ba 33 fields · synced May 26, 2026
- FDA 510(k) K143630 1 fields · synced May 18, 2026