FDA UDI
In Commercial Distribution
🇺🇸 United States
Max Etch 35% Phosphoric Acid Etch 30mL
DI: 00359883005214
·
Model: 345302
·
DEN-MAT HOLDINGS, LLC
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Max Etch 35% Phosphoric Acid Etch 30mL
- Primary DI
- 00359883005214
- Version / Model
- 345302
- Catalog Number
- 345302
- Company Name
- DEN-MAT HOLDINGS, LLC
- Labeler DUNS
- 809857704
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-12
- Public Version
- 2
- Public Version Date
- 2025-10-09
- Public Version Status
- Update
- Public Device Record Key
- 97bb2b4e-a565-4558-95ae-f915c9133810
Device Description
Dental Etchant
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 |
| EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | Dental | 872.4565 | 1 |
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 | 00359883005214 | GS1 |
Customer Contacts
- Phone
- +1(800)433-6628
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 30 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 18 – 29 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 65 – 85 Degrees Fahrenheit