| K-number | K251926 |
| Device name | enCore Impression Material |
| Applicant | Encore Guards |
| Product code | SHI |
| Device class | Class II |
| Decision date | Mar 17, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 872.3660 |
The enCore Impression Material is a vinyl polysiloxane addition-cure dental impression material used to capture accurate impressions of a patient's teeth and gums. It is intended for fabricating custom-fitted night guards and mouthguards for individual patients.
The device is a two-component room-temperature vulcanizing silicone with working times of 40-140 seconds, setting times of 180-275 seconds, Shore A hardness of 70-81, dimensional accuracy of 99.0%, and linear dimensional stability less than 0.8%. It comes in plastic jars for base and catalyst and is manipulated using preformed impression trays.
EN ISO 10993-1:2018 (biological evaluation and risk management), EN ISO 10993-5:2009 (in vitro cytotoxicity), EN ISO 10993-10:2013 (irritation and skin sensitization), and BS EN ISO 10993-11:2018 (systemic toxicity). ISO 4823 standards for consistency types 0-3 are referenced.
The enCore Impression Material is technologically identical to the predicate device (Accusil, K213244) in material composition, chemical properties, processing characteristics, and performance specifications. Both are vinyl polysiloxane impression materials in Class II with the same indications for dental use. Biocompatibility testing met all endpoints, and clinical studies supported the substantial equivalence determination.
View the full FDA submission: accessdata.fda.gov