Adseal Plus Auto-Mix
ADSEAL Plus Auto-Mix is a root canal sealer for permanent sealing after endodontic treatment. It can be used alongside filling materials such as gutta-percha points and is intended for…
ADSEAL Plus Auto-Mix is a root canal sealer for permanent sealing after endodontic treatment. It can be used alongside filling materials such as gutta-percha points and is intended for qualified healthcare personnel trained in its use.
The sealer contains two pastes: an epoxy resin component and an amine-containing component. Mixing them starts an epoxide-amine reaction that causes the material to set inside the prepared root canal.
Listed Item
ADSEAL Plus root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy to mix and adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting. The device consists of two components, the epoxy resin paste (Paste A) and the aminecontaining paste (Paste B); portions of which are mixed prior to insertion into the root canal. This two component system reacts via an epoxide-amine chemical reaction to cause setting. It may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). Paste A and Paste B are contained, separately, with the chambers of a two component plastic syringe, packaged with a disposable applicator. The ADSEAL Plus device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.
Delivery and Supply
The pastes are kept separately in the chambers of a two-component plastic syringe and mixed before insertion into the canal. The device is packaged with a disposable applicator, supplied nonsterile and has a two-year shelf life.
Who Else Makes It
Concentrated in Shanghai (1), Guangxi (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Guilin Kevin Peter Technology Co., Ltd. | Guilin | Guangxi | Manufacturer | 13 |
| Beijing C-Root Dental Medical Devices Co., Ltd. | Beijing | Beijing | Manufacturer | 6 |
| Enpuno Biotechnology Co., Ltd. | Changsha | Hunan | Manufacturer | 1 |
Record
| Listed by | Meta Biomed Co., Ltd., South Korea |
|---|---|
| FDA product code | KIF |
| Device type | Resin, Root Canal Filling |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3820 |
| Establishment | Repacker / relabeller, Private-label distributor, Manufacturer |
| 510(k) | K230010 |
| Record published | 2023-06-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9478 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Brasseler USA | Peter Brasseler Holdings, LLC | 19 |
| Root canal repair materials | Enpunuo Biotechnology Co., Ltd. | 12 |
| Diapaste | Diadent Group Intl., Inc. | 10 |
| NeoMTA Plus | Avalon Biomed, Inc. | 10 |
| C-Root | Beijing C-Root Dental Medical Devices Co., Ltd. | 10 |
| MetaSEAL™ | Parkell, Inc. | 7 |
| Henry Schein | Henry Schein, Inc. | 7 |
| Grey MTA Plus | Avalon Biomed, Inc. | 7 |
| EndoREZ | Ultradent Products Inc. | 6 |
| Cerafill RCS | Prevest Denpro Limited | 6 |
| MTA Angelus | Angelus Industria DE Produtos Odontologicos S/A | 5 |
| Injectable Root Canal Bioceramic Sealer(nRoot SP) | Enpunuo Biotechnology Co., Ltd. | 5 |
Showing 12 of 204. All products under Resin, Root Canal Filling
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K232299 | 2023-09-29 |
| K230010 | 2023-04-13 |
| K210904 | 2021-06-30 |
| K202617 | 2021-04-14 |
| K190503 | 2019-06-07 |
| K190510 | 2019-05-29 |
| K042769 | 2004-11-24 |
| K032605 | 2003-10-08 |
| K032603 | 2003-10-07 |
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.