Cleared Traditional

Custom Abutments

K243278 · Institut Straumann AG · Dental

Feb 2025

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K243278 is an FDA 510(k) clearance for the Custom Abutments, a Abutment, Implant, Dental, Endosseous (Class II — Special Controls, product code NHA), submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on February 21, 2025, 128 days after receiving the submission on October 16, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K243278 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 16, 2024
Decision Date	February 21, 2025
Days to Decision	128 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NHA — Abutment, Implant, Dental, Endosseous
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3630
Definition	To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.