FDA UDI
In Commercial Distribution
🇺🇸 United States
Vista-Red Caries Unit Dose
DI: 10818207020045
·
Model: 317009
·
Vista Dental
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
30
Basic Information
- Brand Name
- Vista-Red Caries Unit Dose
- Primary DI
- 10818207020045
- Version / Model
- 317009
- Company Name
- Vista Dental
- Labeler DUNS
- 036623932
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2018-07-31
- Public Version
- 1
- Public Version Date
- 2018-08-31
- Public Version Status
- New
- Public Device Record Key
- 738ede0c-bfe4-47f3-a758-828c2dbfeb47
Device Description
Glycol based solution to facilitate removal of carious dentin. Unit dose includes (30) individually packaged vials & brush applicators
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LFC | Device, Caries Detection | Dental | 872.1740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60408 | Dental caries detecting stain | A liquid substance intended for use in dentistry as a staining agent to detect early stage dental caries and/or to monitor the progress of caries. It typically consists of two solutions (e.g., metal fluorides) that are applied separately to the suspect area of the tooth/teeth, and change colour in the presence of the caries-producing bacteria or bacterial residues, and/or remnants of the tooth structure from a carious lesion. The staining produced can be monitored over time to assess the progression/remission of the caries. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10818207020045 | GS1 | ||||
| Unit of Use | 00818207020048 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K955445 | 000 |