FDA UDI
In Commercial Distribution
🇺🇸 United States
Ortek Therapeutics, Inc.
DI: 00858197004062
·
Model: Ortek-ECD
·
ORTEK THERAPEUTICS, INC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ortek Therapeutics, Inc.
- Primary DI
- 00858197004062
- Version / Model
- Ortek-ECD
- Company Name
- ORTEK THERAPEUTICS, INC
- Labeler DUNS
- 849786749
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-21
- Public Version
- 1
- Public Version Date
- 2022-12-29
- Public Version Status
- New
- Public Device Record Key
- 7e144809-26a0-477c-b487-437263e3cbce
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| NBL | Laser, Fluorescence Caries Detection | Dental | 872.1745 | 2 |
| LFC | Device, Caries Detection | Dental | 872.1740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47585 | Dental caries detector, electrical impedance | A mains electricity (AC-powered) device designed to measure resistance to the flow of electric current across teeth for the diagnosis of early stage dental caries and/or to monitor the progress of caries (carious areas being less resistant due to higher concentrations of fluid). It typically consists of a probe with an electrode placed in contact with the tooth to be tested and a second counter electrode, separate from the probe, which is placed in contact with another part of the patient's body to complete an electrical circuit; and an electronic control unit that quantifies the resistance. This procedure is also known as electronic caries monitoring/measurement (ECM). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858197004062 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170822 | 000 |