K-numberK253312
Device nameOrangeCAD Med Abutments
ApplicantOrangecad Med GmbH
Product codeNHA
Device classClass II
Decision dateDec 23, 2025
DecisionSubstantially Equivalent
Regulation872.3630
AI Summary extracted from FDA summary PDF · never regenerated
Intended use

OrangeCAD Med Abutments are dental implant abutments designed to connect endosseous dental implants to prosthetic restorations in the upper or lower jaw. The device includes two abutment designs: straight multi-unit abutments for multi-tooth restorations and healing abutments for single implants. All components are made from titanium alloy (Ti-6Al-4V ELI Grade 23) and are compatible with Straumann Bone Level implants.

Technological characteristics

The device features an internal non-indexed implant connection with abutment diameters ranging from 3.1 to 4.4 mm platform diameter. Multi-unit abutments have a 0.5 to 4.5 mm gingival height and 4.8 mm prosthetic diameter, while healing abutments have 3 to 5 mm gingival height. Both designs support cement-retained or screw-retained prostheses and are provided in a straight (0°) configuration only. The device is sterilized via steam sterilization at the end-user level.

Test standards cited

Biocompatibility testing per ISO 10993-5 (cytotoxicity), sterilization validation per ISO 17665-1 and ISO 14937, and MRI safety assessment using published literature on metal alloy behavior in magnetic fields. Reverse engineering studies were performed to validate physical compatibility with Straumann Bone Level implant systems.

Extracted by AI from the official FDA summary PDF →
Source

View the full FDA submission: accessdata.fda.gov

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