Lilivis
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- Lilivis EUDAMEDOCTiX IntraOral Scanner FDA UDI
- Generic Name
- Intraoral optical scanning system FDA UDI
- Device Name
- Intra Oral Scanner EUDAMEDHuvitz Dental Intraoral Scanner OCT (LSO-100) is a dental 3D scanner intended to be used to digitally record topographical characteristics of teeth and surrounding tissues. LSO-100 produces 3D scans for use in computer-assisted design and manufacturing of dental restorations. FDA UDI
- Model / Reference
- LS-100, LSO-100 EUDAMEDY4XXCL-24-00001 EUDAMEDLSO-100 FDA UDI
- Description
- Huvitz Dental Intraoral Scanner OCT (LSO-100) is a dental 3D scanner intended to be used to digitally record topographical characteristics of teeth and surrounding tissues. LSO-100 produces 3D scans for use in computer-assisted design and manufacturing of dental restorations. FDA UDI
Identifiers
- Catalog Number
- Y4XXCL-24-00001 FDA UDI
- Primary DI / UDI-DI
- 08800019600961 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000196DT001CN EUDAMED
- Direct Marketing DI
- 08800019600961 EUDAMED
- FDA Product Code
- NOF FDA UDI
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
- GMDN Term
- Intraoral optical scanning system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3661 FDA UDI
- Market of Registration
- Germany 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
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, temporary, preformed, single-use
Lilivis by Huvitz Co., Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000196DT001CN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Huvitz Co., Ltd.
- EUDAMED SRN
- KR-MF-000015802
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 3036d019-1394-40a0-bca2-a0b157c97d11 61 fields · synced Jul 26, 2026
- FDA UDI 6a64e069-ff52-46f5-9499-901d7dd9db88 35 fields · synced May 30, 2026