Roeko Calcium Hydroxide Plus Points
15 catalogue numbers from ISO 30, listed by Coltène/Whaledent AG, Switzerland, under Liner, Cavity, Calcium Hydroxide. 1 manufacturer in China is registered for this product code.
1manufacturer
15catalogue numbers in this listing
Who Else Makes It
Registered in Guangxi.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Kevin Peter Technology Co., Ltd. | Guilin | Guangxi | Manufacturer | 13 |
Record
| Listed by | Coltène/Whaledent AG, Switzerland |
|---|---|
| FDA product code | EJK |
| Device type | Liner, Cavity, Calcium Hydroxide |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3250 |
| Record published | 2018-02-01 |
| Record revised | 2022-03-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 25 °C; Storage environment temperature up to 77 °F; Special storage condition: keep dry |
| Distribution end date | 2021-01-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ISO 30 | ISO 30 | 60 | Withdrawn |
| ASSORTMENT ISO 45-80 | ASSORTMENT contains ISO 45, ISO 50, ISO 55, ISO 60, ISO 70 and ISO 80 | Withdrawn | |
| ISO 70 | ISO 70 | 60 | Withdrawn |
| SAMPLE | Withdrawn | ||
| ISO 25 | ISO 25 | 60 | Withdrawn |
| ISO 55 | ISO 55 | 60 | Withdrawn |
| ASSORTMENT ISO 15-40 | ASSORTMENT contains ISO 15, ISO 20, ISO 25, ISO 30, ISO 35 and ISO 40 | Withdrawn | |
| ISO 45 | ISO 45 | 60 | Withdrawn |
| ISO 80 | ISO 80 | 60 | Withdrawn |
| ISO 50 | ISO 50 | 60 | Withdrawn |
| ISO 15 | ISO 15 | 60 | Withdrawn |
| ISO 35 | ISO 35 | 60 | Withdrawn |
| ISO 20 | ISO 20 | 60 | Withdrawn |
| ISO 40 | ISO 40 | 60 | Withdrawn |
| ISO 60 | ISO 60 | 60 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 14 |
| Calcigel | Prevest Denpro Limited | 8 |
| TheraCal LC | Bisco, Inc. | 8 |
| Hydroxyline | Taub Products | 8 |
| GC Fuji Lining™ | GC America Inc. | 7 |
| TheraCal PT | Bisco, Inc. | 6 |
| Super Seal | Phoenix Dental, Inc. | 5 |
| Cal LC | Prevest Denpro Limited | 4 |
| AxioCAL LC | Axiodent Inc. | 4 |
| Ultra-Blend Plus | Ultradent Products Inc. | 4 |
| AxioCAL | Axiodent Inc. | 4 |
| UltraCal XS | Ultradent Products Inc. | 4 |
Showing 12 of 84. All products under Liner, Cavity, Calcium Hydroxide
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.