FDA UDI
In Commercial Distribution
🇺🇸 United States
KROMALGIN Piu 453g
DI: 08033712560229
·
Model: 002000
·
VANNINI DENTAL INDUSTRY SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- KROMALGIN Piu 453g
- Primary DI
- 08033712560229
- Version / Model
- 002000
- Catalog Number
- 002000
- Company Name
- VANNINI DENTAL INDUSTRY SRL
- Labeler DUNS
- 436650394
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-06
- Public Version
- 3
- Public Version Date
- 2026-03-16
- Public Version Status
- Update
- Public Device Record Key
- 5d91c473-7d40-4fbb-830a-77833ac8292e
Device Description
Alginate for dental impressions
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
- MR Safe
- Direct Marking Exempt
- Yes
- 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 |
|---|---|---|---|---|
| ELW | MATERIAL, IMPRESSION | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35863 | Alginate dental impression material | A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18033712560226 | GS1 | BOX | 24 | In Commercial Distribution | |
| Primary | 08033712560229 | GS1 |
Customer Contacts
- Phone
- +39055644698
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 27280 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 28 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Handling Environment Temperature