UltraCal XS
UltraCal XS is a premixed calcium hydroxide paste for direct dental application, including temporary root-canal dressing and specified pulp or root-repair procedures. Its aqueous…
UltraCal XS is a premixed calcium hydroxide paste for direct dental application, including temporary root-canal dressing and specified pulp or root-repair procedures. Its aqueous formulation has an alkaline pH of 12.0 to 12.5.
The paste contains 35 percent calcium hydroxide with water, barium sulfate, propylene glycol and a cellulose thickener. Barium sulfate makes the material visible on radiographs.
Listed Item
UltraCal XS Econo Refill
Delivery and Applications
A 1.2 mL syringe with disposable delivery tips places the paste at the treatment site. Uses include direct or indirect pulp capping, vital pulpotomy, apexification and specified perforation or resorption procedures. It is a treatment paste and is not intended to provide a permanent root-canal seal.
Who Else Makes It
Concentrated in Shanghai (1), Guangxi (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Guilin Kevin Peter Technology Co., Ltd. | Guilin | Guangxi | Manufacturer | 13 |
| Beijing C-Root Dental Medical Devices Co., Ltd. | Beijing | Beijing | Manufacturer | 6 |
| Enpuno Biotechnology Co., Ltd. | Changsha | Hunan | Manufacturer | 1 |
Record
| Listed by | Ultradent Products Inc., United States |
|---|---|
| FDA product code | KIF |
| Device type | Resin, Root Canal Filling |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3820 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K211905 |
| Record published | 2023-06-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 27 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5144 | In distribution | |
| 5145 | In distribution | |
| 5145 | In distribution | |
| 5149 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Brasseler USA | Peter Brasseler Holdings, LLC | 19 |
| Root canal repair materials | Enpunuo Biotechnology Co., Ltd. | 12 |
| Diapaste | Diadent Group Intl., Inc. | 10 |
| NeoMTA Plus | Avalon Biomed, Inc. | 10 |
| C-Root | Beijing C-Root Dental Medical Devices Co., Ltd. | 10 |
| MetaSEAL™ | Parkell, Inc. | 7 |
| Henry Schein | Henry Schein, Inc. | 7 |
| Grey MTA Plus | Avalon Biomed, Inc. | 7 |
| EndoREZ | Ultradent Products Inc. | 6 |
| Cerafill RCS | Prevest Denpro Limited | 6 |
| MTA Angelus | Angelus Industria DE Produtos Odontologicos S/A | 5 |
| Injectable Root Canal Bioceramic Sealer(nRoot SP) | Enpunuo Biotechnology Co., Ltd. | 5 |
Showing 12 of 204. All products under Resin, Root Canal Filling
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211905 | 2021-10-13 |
| K071106 | 2007-05-08 |
| K042756 | 2004-10-26 |
| K992097 | 1999-10-26 |
| K971899 | 1997-06-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.