Temp-Bond NE
Temporary Crown and Bridge Cement Zinc Oxide Unidose
3manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
8recalls on this code
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 | Kerr Corporation, United States |
|---|---|
| FDA product code | EMA |
| Device type | Cement, Dental |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3275 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K003658 |
| Record published | 2016-08-31 |
| Record revised | 2025-03-17 (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 2 to 25 °C |
| Sizes | Weight 120 g |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 31973 | Weight 120 g | 50 | In distribution |
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 |
|---|---|
| K191548 | 2019-10-11 |
| K123595 | 2013-02-19 |
| K062519 | 2006-10-19 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-02-25 | Class II | Process control | An issue within production process used to package trial kits let to the inclusion of the incorrect bonding agent for the kit. Use of the incorrect bonding agent may lead to increased risk of bond failures. | 111 kits | 2021-05-19 |
| 2011-07-08 | Not classified | Pending | Pentron is voluntarily recalling the Breeze Self Adhesive Resin Cement because it was discovered that there may be a curing problem that may cause cemented crowns to fall off after use of the product. | 336 units | 2013-06-28 |
| 2011-03-17 | Not classified | Other | The firm initiated a recall because the product sets faster than specified in the “Directions for Use” and in release specifications. | 157 | 2014-01-22 |
| 2011-03-03 | Not classified | Nonconforming Material/Component | The resin material separates when the product is extruded from the syringe. Although there are no safety issues related with this situation, please refrain from using the affected product. | 100 Units | 2012-01-09 |
| 2011-03-03 | Not classified | Nonconforming Material/Component | The recall was initiated because Pentron Clinical has confirmed that the TempSpan Temporary Cement may have black plastic material on the surface of the paste, and it may set faster than specified. | 627 units total (601 units in the US) | 2012-03-14 |
| 2010-12-02 | Not classified | Nonconforming Material/Component | The recall was initiated because Pentron Clinical has confirmed that the Breeze Self-Adhesive Resin Cement exhibits faster than expected gel and set times. If the work time is exceeded when using this material, it could possibly result in | 622 units total (12 units in US) | 2012-02-24 |
| 2009-09-09 | Not classified | Nonconforming Material/Component | The recall was initiated because the catalyst portion of the syringe may have polymerized, therefore making the product unusable. | 13,518 units | 2011-12-12 |
| 2006-08-14 | Not classified | Other | Low Bonding performance: The affected lots of product may not activate properly, which may cause lower than expected bonding performance (due to a low level of chemical cure initiator in the lots manufactured) | 2,007 | 2012-08-03 |
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.