Any-Paste

Any-Paste is a biocompatible root canal filling material used for temporary filling of root canals after endodontic surgery and for vital pulpotomy in deciduous teeth. It is a water-soluble, pre-mixed paste delivered via syringe that can be easily cleaned and removed, containing calcium hydroxide, barium sulfate, polyethylene glycol 400, aluminum oxide, and titanium oxide.

Any-Paste has a flow of 22 mm, film thickness of 15.3 μm, radio-opacity of 3.5 mm, and pH greater than 11. It is delivered in a 2g syringe with a disposable tip, has a shelf-life of 3 years, and is classified for prolonged exposure (exceed 24 hours but not 30 days). These characteristics are substantially similar to the predicate device with minor differences in raw materials and shelf-life.

ISO 6876 for performance testing (appearance, weight, packaging, flow, film thickness, radio-opacity, pH); ISO 10993-1 for biological evaluation; ISO 10993-5:2009 for in vitro cytotoxicity; ISO 10993-11:2017 for systemic toxicity; ISO 10993-10:2021 for skin sensitization.

Any-Paste is substantially equivalent to the predicate device Metapaste Plus because they share identical indications for use, same product code (KIF), same intended users (licensed dentists), same technological standard (ISO 6876), and comparable technological characteristics. Minor differences in raw materials and shelf-life do not raise safety or effectiveness concerns based on performance and biocompatibility test results.