Hygenic
Calcium Hydroxide Points #15-40
1manufacturer
14catalogue 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 | Coltene/Whaledent Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | EJK |
| Device type | Liner, Cavity, Calcium Hydroxide |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3250 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K973539 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry; Storage environment temperature up to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| H01500 | In distribution | ||
| H01516 | 60 | In distribution | |
| H01515 | 60 | In distribution | |
| H01513 | 60 | In distribution | |
| H01514 | 60 | In distribution | |
| H01508 | 60 | In distribution | |
| H01509 | 60 | In distribution | |
| H01507 | 60 | In distribution | |
| H01505 | 60 | In distribution | |
| H01510 | 60 | In distribution | |
| H01512 | 60 | In distribution | |
| H01501 | In distribution | ||
| H01506 | 60 | In distribution | |
| H01511 | 60 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Roeko Calcium Hydroxide Plus Points | Coltène/Whaledent AG | 15 |
| 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.