ETCH-ALL™ Dental Etching Gel
- Primary DI
- D701EA62
- Brand
- ETCH-ALL™ Dental Etching Gel
- Company
- PULPDENT CORPORATION
- Model
- EA6
- Device description
- 6 mL syringe 10% Phosphoric Acid
- Published
- 2016-07-28
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| EBF | Material, Tooth Shade, Resin |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EBF | Material, Tooth Shade, Resin | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D701EA62 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dental etching solution | An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused. |
Device Sizes
| Type | Value | Unit |
|---|
| Total Volume | 6 | Milliliter |
Regulatory Flags
- DUNS number
- 001006089
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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