Premise Indirect
Refill - Primary Dentin A3.5
10manufacturers in China registered for this device type
46catalogue numbers in this listing
9510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Shandong (2), Jilin (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Hangzhou SHINING3D Dental Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 7 |
| Shenzhen Piocreat 3D Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Shenzhen Upcera Dental Technology Co., Ltd. | Shenzhen | Guangdong | Private-label distributor | 6 |
| Sincera Technology (Changchun) Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
| Sino-Dentex Co., Ltd. | Changchun | Jilin | Manufacturer | 2 |
Record
| Listed by | Kerr Corporation, United States |
|---|---|
| FDA product code | EBF |
| Device type | Material, Tooth Shade, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3690 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-08-01 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Special storage condition: Store at ambient temperature |
| Sizes | Weight 4 to 5 g |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 33617 | Weight 5 g | In distribution | |
| 33587 | Weight 5 g | In distribution | |
| 33616 | Weight 5 g | In distribution | |
| 33615 | Weight 5 g | In distribution | |
| 33612 | Weight 5 g | In distribution | |
| 33589 | Weight 5 g | In distribution | |
| 33604 | Weight 5 g | In distribution | |
| 33593 | Weight 5 g | In distribution | |
| 33622 | Weight 4 g | In distribution | |
| 33620 | Weight 5 g | In distribution | |
| 33800 | 123 | In distribution | |
| 33585 | Weight 5 g | In distribution | |
| 33588 | Weight 5 g | In distribution | |
| 33609 | Weight 5 g | In distribution | |
| 33605 | Weight 5 g | In distribution | |
| 33797 | 179 | In distribution | |
| 33798 | 179 | In distribution | |
| 33623 | Weight 4 g | In distribution | |
| 33613 | Weight 5 g | In distribution | |
| 33595 | Weight 5 g | In distribution | |
| 33608 | Weight 5 g | In distribution | |
| 33621 | Weight 4 g | In distribution | |
| 33610 | Weight 5 g | In distribution | |
| 33600 | Weight 5 g | In distribution | |
| 33594 | Weight 5 g | In distribution | |
| 33624 | Weight 4 g | In distribution | |
| 33799 | 123 | In distribution | |
| 33597 | Weight 5 g | In distribution | |
| 33611 | Weight 5 g | In distribution | |
| 33619 | Weight 5 g | In distribution | |
| 33607 | Weight 5 g | In distribution | |
| 33603 | Weight 5 g | In distribution | |
| 33592 | Weight 5 g | In distribution | |
| 33606 | Weight 5 g | In distribution | |
| 33601 | Weight 5 g | In distribution | |
| 33598 | Weight 5 g | In distribution | |
| 33602 | Weight 5 g | In distribution | |
| 33599 | Weight 5 g | In distribution | |
| 33591 | Weight 5 g | In distribution | |
| 33596 | Weight 5 g | In distribution | |
| 33590 | Weight 5 g | In distribution | |
| 33618 | Weight 5 g | In distribution | |
| 33586 | Weight 5 g | In distribution | |
| 33626 | Weight 4 g | In distribution | |
| 33625 | Weight 4 g | In distribution | |
| 33614 | Weight 5 g | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tooth Shade Resin Material | Liaoning Upcera Co., Ltd. | 4,808 |
| Gradia® | GC America Inc. | 548 |
| G-CAM | Graphenano Dental, SL | 320 |
| Vitavm LC | Vita – Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 261 |
| G-aenial™ | GC America Inc. | 225 |
| Ena HRI ® | Micerium SPA | 221 |
| Mazic Duro | Vericom Co., Ltd. | 206 |
| Ceramage | Shofu Dental Corp. | 204 |
| Filtek™ | 3M Company | 188 |
| SR Nexco | Ivoclar Vivadent Aktiengesellschaft | 181 |
| Aidite | Aidite (Qinhuangdao) Technology Co., Ltd. | 166 |
| Tetric EvoCeram | Ivoclar Vivadent Aktiengesellschaft | 163 |
Showing 12 of 2,059. All products under Material, Tooth Shade, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K221255 | 2022-08-31 |
| K162257 | 2016-11-07 |
| K103351 | 2011-01-20 |
| K100083 | 2010-03-19 |
| K093484 | 2010-01-27 |
| K091023 | 2009-05-21 |
| K090292 | 2009-04-03 |
| K081695 | 2008-08-12 |
| K060472 | 2006-04-28 |
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 |
|---|---|---|---|---|---|
| 2013-09-13 | Class II | Mixed-up of materials/components | Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the | 197 units | 2014-02-11 |
| 2011-03-31 | Not classified | Nonconforming Material/Component | Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it | 41,744 units | 2012-08-09 |
| 2011-03-31 | Not classified | Nonconforming Material/Component | Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it | 41,744 units | 2012-08-09 |
| 2011-03-31 | Not classified | Nonconforming Material/Component | Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it | 41,744 units | 2012-08-09 |
| 2011-03-31 | Not classified | Nonconforming Material/Component | Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it | 41,744 units | 2012-08-09 |
| 2011-03-31 | Not classified | Nonconforming Material/Component | Pentron Clinical is voluntarily recalling all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it | 41,744 units | 2012-08-09 |
| 2011-03-03 | Not classified | Nonconforming Material/Component | The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude. | 77,289 Units total | 2012-10-05 |
| 2011-03-03 | Not classified | Nonconforming Material/Component | The recall was initiated because Pentron Clinical has confirmed that the Flow Tec Nano-Hybrid Flowable Composite material has been found to be difficult to extrude. | 77,289 Units total | 2012-10-05 |
| 2010-10-22 | Not classified | Nonconforming Material/Component | The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. | 772 units in total | 2012-02-13 |
| 2010-10-22 | Not classified | Nonconforming Material/Component | The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. | 771 units in total | 2012-02-13 |
| 2010-10-22 | Not classified | Nonconforming Material/Component | The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. | 771 units | 2012-02-13 |
| 2010-10-22 | Not classified | Nonconforming Material/Component | The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude. | 772 units in total | 2012-02-13 |
| 2010-08-19 | Not classified | Nonconforming Material/Component | A recall was initiated because Pentron Clinical has confirmed that the Fusio Liquid Dentin is not as flowable as ideally expected. | 382 units total (207 units in US) | 2012-02-28 |
| 2009-02-23 | Not classified | Labeling mix-ups | Sybron Dental Specialties is initiating a field correction on the Herculite Ultra, a dental composite restorative material, due to a mistake in the directions for use located in the Herculite technique card. | 442 | 2012-03-19 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
| 2008-09-05 | Not classified | Component design/selection | Material stiff: Material in several lots of Premise Unidose appears to stiffen and become difficult to extrude over time. | 22,478 packs for all affected lots | 2012-03-07 |
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.