| K-number | K253797 |
| Device name | One-Stop |
| Applicant | Mediclus Co., Ltd. |
| Product code | MVL |
| Device class | Class U |
| Decision date | Feb 27, 2026 |
| Decision | Substantially Equivalent |
| Regulation | — |
One-Stop is a paste-type gingival retraction paste containing aluminum chloride that provides temporary retraction and hemostasis of the gingival margin during dental procedures such as taking impressions, cementation, and cavity preparation. The paste is delivered via syringe with a disposable tip and can be removed by rinsing with water after use.
One-Stop has similar technological characteristics to the predicate GingiDent device, including the same indications for use, similar material composition (both aluminum chloride-based), comparable application time of 2-3 minutes versus 2 minutes, similar delivery method via syringe, and biocompatibility. Minor differences include aluminum chloride concentration (18.3% vs 16.42%), pH (0.7 vs 3.22), and slight variations in flow and weight, but these do not raise safety or effectiveness concerns.
ISO 6876 for performance testing; ISO 10993-1 for biological evaluation framework; ISO 10993-5:2009 for in vitro cytotoxicity; ISO 10993-23:2021 for irritation testing (replaced with pH test); ISO 10993-10:2021 for skin sensitization testing.
One-Stop is substantially equivalent to the predicate GingiDent Gingival Retraction Paste because both devices share identical indications for use, the same technological characteristics (aluminum chloride-based astringent paste with syringe delivery), equivalent biocompatibility, and similar performance profiles. Minor raw material differences do not raise safety or effectiveness concerns based on performance and biocompatibility test results.
View the full FDA submission: accessdata.fda.gov