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Evadyne® is a light cured single-component material for the temporary restoration of crowns, bridges, or similar dental prostheses. Evadyne is intended for the general dental patient population.

NeoDental Chemical Products, Inc, (NeoDental) wishes to submit their Evadyne® Temporary Crown and Bridge Resin for 510(k) clearance. Evadyne®, (shown in Figure 1) is a yellowish translucent, light-cured temporary restoration material for direct filling. After curing, Evadyne can be removed in one piece when the permanent restoration is to be placed. Evadyne® is packaged as a multiple use syringe, with new tips being attached for each patient. The syringe can be used until empty. The syringe is kept capped between uses and is fitted with a new tip just prior to use. The syringe is cleaned with an alcohol wipe before and after use.

Cavios® Cavity Liner is to be applied to the interior of a prepared cavity prior to the insertion of restorative materials. Cavity Liner is indicated for use in the general dental population.

Cavios®, (shown in Figure 1) is a light cured single-component yellow-white paste for use as a dentin liner and base. The product is preloaded into syringes and expressed via the syringe plunger through single-use disposable tips. Following the application, Cavios® is cured (polymerized) with a light source (approximately 470 nm). Following polymerization, the restorative materials, amalgam, etc., may be placed. Cavios® is packaged as a multiple use syringe, with new tips being attached for each patient. The syringe can be used until empty. The syringe is kept capped between uses and is fitted with a new tip just prior to use. The syringe is cleaned with an alcohol wipe before and after use.

For use to stimulate the healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals, and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectomy, or for apexegenesis or apexification, and / or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.

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For use in the sealing of prepared root canals in adult or decidious teeth prior to final filling with gutta percha or other acceptable root canal filler. Used to promote healing effects and to help prevent bacterial contamination of the canal.

Endodontic Sealer