FDA UDI
In Commercial Distribution
🇺🇸 United States
Porcelain Etch
DI: 10818207020182
·
Model: 502512
·
Vista Dental
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
Basic Information
- Brand Name
- Porcelain Etch
- Primary DI
- 10818207020182
- Version / Model
- 502512
- Company Name
- Vista Dental
- Labeler DUNS
- 036623932
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- 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
- 8d9c39d7-078c-4354-89a8-1ac74bb5f031
Device Description
Viscous 9.5% Hydrofluoric Acid Solution. For porcelain veneers and inlays prior to cementation or repairs. Refill kit includes (2) 1.2mL prefilled etch syringes, (25) Spira-Flo™ brush tips
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
- 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 |
|---|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62474 | Dental prosthesis priming agent | A material primarily intended to be applied to a dental prosthesis (i.e., indirect restorative) and/or prosthesis component to promote bonding (e.g., to a composite resin cement, composite-based stain, or another prosthesis component). It may be referred to as a primer and includes compounds such as an unfilled-resin or silane-based agent; an applicator may also be included. The material is not intended to be used as a dentine bonding or dentine priming agent. 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 | 10818207020182 | GS1 | ||||
| Unit of Use | 00818207020185 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K933766 | 000 |