Silane
Catalogue number N04EA, listed by Kerr Corporation, United States, under Agent, Tooth Bonding, Resin. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
11recalls on this code
Who Else Makes It
Concentrated in Jilin (2), Liaoning (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| CAO (China) Medical Equipment Company, Limited | Langfang | Hebei | Contract manufacturer | 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 | KLE |
| Device type | Agent, Tooth Bonding, Resin |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3200 |
| 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 |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 3 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N04EA | Total Volume 3 ml | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Epic® | Parkell, Inc. | 22 |
| All-Bond Universal | Bisco, Inc. | 18 |
| Henry Schein | Henry Schein, Inc. | 16 |
| Peak Universal Bond | Ultradent Products Inc. | 16 |
| Brush&Bond® | Parkell, Inc. | 16 |
| All-Bond 2 | Bisco, Inc. | 15 |
| The Orthodontic Store | Young Innovations Inc. | 15 |
| All-Bond 3 | Bisco, Inc. | 13 |
| Scotchbond™ Universal | 3M Deutschland GmbH | 13 |
| Select HV Etch w/BAC | Bisco, Inc. | 12 |
| Prelude | Danville Materials, LLC | 12 |
| Jade | Dharma Research, Inc. | 12 |
Showing 12 of 609. All products under Agent, Tooth Bonding, Resin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222830 | 2023-01-12 |
| K182162 | 2018-11-07 |
| K101423 | 2010-07-30 |
| K100347 | 2010-04-30 |
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 | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-05-27 | Not classified | Nonconforming Material/Component | The recall was initiated because Pentron Clinical has confirmed that various lots of Bond-1 Primer/Adhesive have been found to have gelled and therefore becomes unusable. | 30,276 units total | 2012-03-02 |
| 2009-08-24 | Not classified | Nonconforming Material/Component | Some of the material has been found to be gelled and therefore becomes unusable. | 1,400 | 2012-02-24 |
| 2006-08-29 | Not classified | Other | Mis-pack/mis-label: The OptiBond Self Etch Primer and OptiBond Solo Plus Adhesive in the chambers were mis-packaged/mis-labeled in reverse order. Application of these products in reverse order may result in compromised bond strength. | 247 Kits (50 unidose pouches/Kit) | 2012-08-03 |
| 2006-03-03 | Not classified | Other | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. | 85 | 2012-03-07 |
| 2006-03-03 | Not classified | Other | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. | 34 | 2012-03-07 |
| 2006-03-03 | Not classified | Other | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. | 6898 | 2012-03-07 |
| 2006-03-03 | Not classified | Other | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. | 161 | 2012-03-07 |
| 2006-03-03 | Not classified | Other | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. | 40 | 2012-03-07 |
| 2006-03-03 | Not classified | Other | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. | 16 | 2012-03-07 |
| 2006-03-03 | Not classified | Other | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. | 72 | 2012-03-07 |
| 2006-03-03 | Not classified | Other | The affected lot of product may not activate properly throughout the full intended shelf life and may result in lower than expected bonding performance. | 10 | 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.