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Luvis Chair (LC700C)
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
510(k) K233921Ref LC700C
Identity
- Trade Name
- Luvis Chair EUDAMED
- Device Name
- Luvis Chair EUDAMED
- Model / Reference
- LC700C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800313232035 EUDAMED
- Basic UDI-DI
- 88000530LC9N EUDAMED
- Direct Marketing DI
- 08800313232035 EUDAMED
- 510(k) Number
- K233921 FDA 510(k)
- FDA Product Code
- KLC FDA 510(k)
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.6250 FDA 510(k)
- Regulation Number
- 872.6250 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Luvis Chair (LC700C) by Dentis Co. , Ltd — Class I — MDR, FDA_510K — listed in FDA 510(k), EUDAMED — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K233921 | Class I | Active |
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Manufacturer
- Manufacturer
- Dentis Co. , Ltd
- FDA Applicant
- Dentis Co., Ltd.
Sources (2)
- FDA 510(k) K233921 24 fields · synced Aug 2, 2026
- EUDAMED 242b0473-7582-4ee3-89c7-bfdebed4a53e 61 fields · synced Aug 2, 2026