FDA UDI
In Commercial Distribution
🇺🇸 United States
ETCH-RITE™ DENTAL ETCHING GEL
DI: D701ET50R2
·
Model: ET50R
·
PULPDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
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Basic Information
- Brand Name
- ETCH-RITE™ DENTAL ETCHING GEL
- Primary DI
- D701ET50R2
- Version / Model
- ET50R
- Company Name
- PULPDENT CORPORATION
- Labeler DUNS
- 001006089
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2016-08-11
- Public Version
- 3
- Public Version Date
- 2025-10-09
- Public Version Status
- Update
- Public Device Record Key
- 1cf2777c-8a55-4602-a552-527d8a422cef
Device Description
Jumbo Refill: 2x25 mL (69 gm) syringe 38 Phosphoric Acid
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
- No
- 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 |
|---|---|---|---|---|
| 36153 | Dental tooth-etching solution | An acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. 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 | D701ET50R2 | HIBCC | ||||
| Unit of Use | D701ET50R1 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 25 | Milliliter |