TheraCal LC
TheraCal LC 0.25g Single Syringe SMPL
1manufacturer
8catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Bisco, Inc., United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K063237 |
| Record published | 2022-11-17 |
| Record revised | 2022-11-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 20 to 25 °C |
| Distribution end date | 2022-11-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H-3301P | In distribution | |
| H-3301 | In distribution | |
| H-33014P | In distribution | |
| H-3302S | In distribution | |
| H-3301P | Withdrawn | |
| H-3301 | Withdrawn | |
| H-33014P | Withdrawn | |
| H-3302S | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Roeko Calcium Hydroxide Plus Points | Coltène/Whaledent AG | 15 |
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 14 |
| Calcigel | Prevest Denpro Limited | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180344 | 2018-04-05 |
| K143292 | 2015-08-04 |
| K063237 | 2006-12-08 |
| K033521 | 2004-01-16 |
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.