TheraBase Ca
TheraBase Ca is a self-adhesive, self-etching, dual-cured resin cement and base or liner. It is intended for luting crowns, bridges, inlays, onlays and posts, or lining beneath…
TheraBase Ca is a self-adhesive, self-etching, dual-cured resin cement and base or liner. It is intended for luting crowns, bridges, inlays, onlays and posts, or lining beneath restorations. The paste-and-paste material is delivered from a dual syringe without a separate etch, primer or bonding step.
The methacrylate resin contains amorphous silica and Portland cement filler and releases calcium. It is radiopaque and supplied in a Natural shade. The Ca formulation does not contain fluoride, distinguishing it from the separately described TheraBase formulation.
Listed Item
TheraBase Ca 1g Dual Syringe Pkg
Handling Properties
The stated working time is at least one minute at approximately room temperature, with setting in under five minutes at body temperature. The tested film thickness is below 35 micrometers. These properties apply to the mixed cement used beneath or between the restoration and prepared tooth.
Who Else Makes It
Concentrated in Shandong (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
Record
| Listed by | Bisco, Inc., United States |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K192007 |
| Record published | 2022-10-10 |
| Record revised | 2022-10-12 (version 3) |
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 2 to 25 °C |
| Distribution end date | 2022-10-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H-3502PS | In distribution | |
| H-3502S | In distribution | |
| H-3501 | In distribution | |
| H-35010P | In distribution | |
| H-35010P | Withdrawn | |
| H-3501 | Withdrawn | |
| H-3502PS | Withdrawn | |
| H-3502S | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GC Fuji II LC® | GC America Inc. | 78 |
| Equia® | GC America Inc. | 73 |
| Riva SC | SDI Ltd. | 72 |
| Denture Base | American Tooth Industries | 61 |
| Riva LC | SDI Ltd. | 59 |
| GC Fuji IX GP® | GC America Inc. | 58 |
| GlasIonomer FX-LC | Shofu Dental Corp. | 45 |
| Henry Schein | Henry Schein, Inc. | 35 |
| Esthet-X®flow Liquid Micro Hybrid | Dentsply LLC | 24 |
| Photac™ Fil Quick Aplicap™ | 3M Deutschland GmbH | 24 |
| Ketac™ Fil Plus Aplicap™ | 3M Deutschland GmbH | 23 |
| Ultra-Bond® | DEN-MAT Holdings, LLC | 23 |
Showing 12 of 780. All products under Cement, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250156 | 2025-07-11 |
| K192007 | 2020-03-17 |
| K161256 | 2016-07-29 |
| K101787 | 2010-10-08 |
| K082449 | 2008-09-25 |
| K060701 | 2006-05-15 |
| K032597 | 2003-11-04 |
| K011159 | 2001-06-08 |
| K940030 | 1994-02-04 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|
| 2008-04-28 | Not classified | Incorrect or no expiration date | During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strengt | 2010-09-14 |
| 2008-04-28 | Not classified | Incorrect or no expiration date | During product stability testing, Bisco determined that after 15 months of storage, BISCEM Self-Adhesive Luting Cement used in self-cure mode only without light-curing may take longer than specified to set, resulting in reduced bond strengt | 2010-09-14 |
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.