Healing Abutment System

The Healing Abutment System is a dental implant component intended for temporary connection to a dental implant to support healing of surrounding soft tissue prior to prosthetic placement. The system includes multiple variants: TS, SS, and US Healing Abutments in various sizes, plus SS and US Scan Healing Abutments with design features to facilitate intraoral digital scanning.

The devices are manufactured from commercially pure titanium (Grade 4, ASTM F67) or titanium alloy (Ti-6Al-4V, ASTM F136). They come in multiple diameter and height combinations ranging from 4.0mm to 9.3mm diameter. The Scan variants incorporate groove and scan marker design features for intraoral scanning. All devices are gamma sterilized and packaged in blister and Tyvek configurations.

ISO 10993-1:2018 (biocompatibility evaluation), ISO 11137-1, ISO 11137-2, ISO 11137-3 (sterilization validation), ASTM F67 (titanium specification), ASTM F136 (titanium alloy specification), FDA guidance on MR safety testing, and ISO 13485 quality management requirements.

The subject devices use identical materials, manufacturing processes, sterilization methods, and packaging as predicate devices (K233194 for TS, K062051/K073247 for SS, K160670/K062030 for US variants, K222778 for Scan variants). Differences are limited to dimensional ranges, implant compatibility, and scan-related design features—all falling within predicate ranges. Since the device performs only soft tissue healing with no load-bearing function, biocompatibility and sterilization testing confirm no new safety or effectiveness concerns arise from these variations.