Elemental Granulate

Elemental Granulate is a thermoplastic, non-resorbable periodontal wound dressing that protects injured periodontal tissue at surgical sites. It is moldable when heated in water or sterile saline to approximately 90°C and hardens into a rigid material within 90 seconds. The device has bacteriostatic properties under in vitro conditions and is for use only by dental professionals.

Elemental Granulate is a thermoplastic polymer with antibacterial additive granules that becomes moldable through heating in hot water or saline, whereas the predicate COE-PAK achieves moldability through a chemical reaction between a catalyst and base. Both devices are non-resorbable, easy-to-use, and moldable for periodontal wound dressing applications. Elemental Granulate differs in that it requires no tackiness testing and can be reworked by re-heating, while COE-PAK requires tackiness checks and finger lubrication.

ISO 10993 (biocompatibility assessment and toxicological risk assessment per ISO 10993-17), ISO 22196 (antibacterial activity testing), and usability engineering risk assessment.

Both devices share the same intended use as periodontal wound dressings and similar safety and performance profiles with comparable anatomical site, environmental use, performance characteristics, biocompatibility, and microbiological status. Although Elemental Granulate differs in chemical composition and preparation method (heating versus chemical mixing), these differences do not affect the fundamental function or safety. Non-clinical testing demonstrates biocompatibility and bacteriostatic activity equivalent to the predicate, supporting substantial equivalence despite the different preparatory handling steps.