FDA UDI
In Commercial Distribution
🇺🇸 United States
DENTIOIII series
DI: 08800005200120
·
Model: DENTIOIII-S
·
HDX WILL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DENTIOIII series
- Primary DI
- 08800005200120
- Version / Model
- DENTIOIII-S
- Company Name
- HDX WILL CORP.
- Labeler DUNS
- 689605054
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-04
- Public Version
- 3
- Public Version Date
- 2022-01-06
- Public Version Status
- Update
- Public Device Record Key
- f9e90711-4391-468c-8236-42d4651b42c7
Device Description
The DENTIOIII-S is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic and cephalometric examinations. It is to be used only by dental practitioners and/or radiologists.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | Dental | 872.1800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43369 | Stationary panoramic dental x-ray system, digital | A diagnostic digital dental x-ray system designed for permanent fixture in one location with an extraoral x-ray sensor and source intended to generate and control x-ray beams to produce panoramic (wide field of view) x-ray images of the teeth, jaw and oral cavity structures. It consists of basic modular configurations that can be upgraded by the addition of hardware, software or other components. The data is either from analogue-to-digital conversion techniques imaging or by digital imaging. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800005200120 | GS1 |
Customer Contacts
- Phone
- +82215882754
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181297 | 000 |