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AlignerFlow LC
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1526Ref 1528Ref 1527Ref 1529
by VOCO GmbH
Identity
- Trade Name
- AlignerFlow LC EUDAMEDFDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- AlignerFlow LC EUDAMEDAlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner attachments within the scope of aligner treatments. syringe 2x2g A2 FDA UDIAlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner attachments within the scope of aligner treatments. syringe 2x2g A1 FDA UDIAlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner attachments within the scope of aligner treatments. syringe sample 1g A1 FDA UDIAlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner attachments within the scope of aligner treatments. syringe 2x2g A3 FDA UDI
- Model / Reference
- 1526 EUDAMEDFDA UDI1527 EUDAMEDFDA UDI1529 EUDAMEDFDA UDI1528 EUDAMEDFDA UDI
- Description
- AlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner attachments within the scope of aligner treatments. syringe 2x2g A2 FDA UDIAlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner attachments within the scope of aligner treatments. syringe 2x2g A1 FDA UDIAlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner attachments within the scope of aligner treatments. syringe sample 1g A1 FDA UDIAlignerFlow LC is a flowable, light-curing and fluorescent nanohybrid composite for aligner attachments within the scope of aligner treatments. syringe 2x2g A3 FDA UDI
Identifiers
- Catalog Number
- 1527 FDA UDI1526 FDA UDI1529 FDA UDI1528 FDA UDI
- Primary DI / UDI-DI
- E22115261 EUDAMEDFDA UDIE22115271 EUDAMEDFDA UDIE22115291 EUDAMEDFDA UDIE22115281 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E22100250000000008G EUDAMED
- 510(k) Number
- K231817 FDA UDI
- FDA Product Code
- DYH FDA UDI
- EMDN Code
- Q0101010201 DENTAL BASE CEMENTS EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3750 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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental composite resin
AlignerFlow LC by VOCO GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K231817 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E22100250000000008G | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (9)
- EUDAMED 32364ba1-1824-4dae-aeb8-a84a16ae4cb5 61 fields · synced Sep 17, 2026
- FDA UDI afd101e7-7f12-4db0-8d09-20f274fabdd2 37 fields · synced May 29, 2026
- FDA UDI 862ecbe4-65be-4e9c-8ab9-6a7b826c4291 37 fields · synced May 30, 2026
- FDA UDI 5437bcee-eb41-40e0-ac8e-b896abf96f0b 37 fields · synced May 30, 2026
- FDA UDI a8775a5c-8953-4da4-8375-8173d0152da9 37 fields · synced May 30, 2026
- EUDAMED a1943ecc-e01c-4d69-8d26-c25df3fe34bf 61 fields · synced Jul 31, 2026
- EUDAMED 25faf4ef-3fb0-4d6c-9c72-352db299f4c1 61 fields · synced Aug 3, 2026
- EUDAMED e0e045af-f87c-4b1e-aada-83b1db6e0a64 61 fields · synced Sep 17, 2026
- FDA 510(k) K231817 1 fields · synced May 18, 2026