FDA UDI
In Commercial Distribution
🇺🇸 United States
OCTiX IntraOral Scanner
DI: 08800019600961
·
Model: LSO-100
·
Huvitz Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OCTiX IntraOral Scanner
- Primary DI
- 08800019600961
- Version / Model
- LSO-100
- Catalog Number
- Y4XXCL-24-00001
- Company Name
- Huvitz Co., Ltd.
- Labeler DUNS
- 688154202
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-26
- Public Version
- 2
- Public Version Date
- 2025-03-26
- Public Version Status
- Update
- Public Device Record Key
- 6a64e069-ff52-46f5-9499-901d7dd9db88
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | Dental | 872.3661 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63669 | Intraoral optical scanning system | An assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800019600961 | GS1 |
Customer Contacts
- Phone
- +82313600082
- [email protected]