K242768 - Customized Abutment and Screw (FDA 510(k) Clearance)

K242768 is an FDA 510(k) clearance for the Customized Abutment and Screw. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Chengdu Besmile Medical Technology Co., Ltd. (Chengdu, CN). The FDA issued a Cleared decision on September 2, 2025 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

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