FDA UDI
In Commercial Distribution
🇺🇸 United States
UltraCal XS
DI: 00883205033253
·
Model: 5145
·
ULTRADENT PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UltraCal XS
- Primary DI
- 00883205033253
- Version / Model
- 5145
- Catalog Number
- 5145
- Company Name
- ULTRADENT PRODUCTS, INC.
- Labeler DUNS
- 013369913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-17
- Public Version
- 1
- Public Version Date
- 2023-06-26
- Public Version Status
- New
- Public Device Record Key
- 3f6ceefa-5d67-4c43-becc-3fe84719d8ed
Device Description
UltraCal XS Refill
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 |
|---|---|---|---|---|
| KIF | Resin, Root Canal Filling | Dental | 872.3820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47232 | Calcium hydroxide dental suspension | A very basic (high pH) calcium hydroxide (Ca(OH)2) solution (also known as slaked lime or milk of lime) intended to be used in dentistry for a variety of purposes including to flush and disinfect root canals and crowns/bridges before final insertion, and to change the viscosity and/or moisten a temporary tooth filling material. It may also encourage the change of fibroblasts (cells which form the connective tissue of the body) into odontoblast-like cells to produce reparative dentine. 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 | 00883205033253 | GS1 |
Customer Contacts
- Phone
- 801-572-4200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211905 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius