FDA UDI
In Commercial Distribution
🇺🇸 United States
DELTON®
DI: D00321031
·
Model: 2103
·
Dentsply Professional
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- DELTON®
- Primary DI
- D00321031
- Version / Model
- 2103
- Company Name
- Dentsply Professional
- Labeler DUNS
- 144140845
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2025-10-09
- Public Version Status
- Update
- Public Device Record Key
- f183a347-7b01-4fd7-a20b-6cef5f38c585
Device Description
EZ Etch 34% Etchant Gel. Contains: 2 Syringes (3 mL each) and 25 Tips.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | D00321032 | HIBCC | Case | 12 | In Commercial Distribution | |
| Primary | D00321031 | HIBCC |
Customer Contacts
- Phone
- +1(800)989-8825
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 3 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 24 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep out of direct sunlight. Causes severe skin burn and eye damage.