FDA UDI
In Commercial Distribution
🇺🇸 United States
Ultra-Blend Plus
DI: 00883205103611
·
Model: 415
·
ULTRADENT PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Ultra-Blend Plus
- Primary DI
- 00883205103611
- Version / Model
- 415
- Catalog Number
- 415
- Company Name
- ULTRADENT PRODUCTS, INC.
- Labeler DUNS
- 013369913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 4
- Public Version Date
- 2019-06-04
- Public Version Status
- Update
- Public Device Record Key
- b05cc0e1-feed-4374-8d61-d620e5b39220
Device Description
Ultra-Blend Plus Kit
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
- 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 |
|---|---|---|---|---|
| EJK | LINER, CAVITY, CALCIUM HYDROXIDE | Dental | 872.3250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62199 | Calcium hydroxide dental cement | A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., pulp capping, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between calcium hydroxide and salicylic acid (or related esters such as butan-1,3-diol disalicylate). It typically includes some additional fillers/components. 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 | 00883205103611 | GS1 |
Customer Contacts
- Phone
- +1(801)572-4200
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K970113 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 27 Degrees Celsius