Cleared Traditional

Straumann InLab Validated Workflow

K243478 · Institut Straumann AG · Dental

Feb 2025

Decision

103d

Days

Class 2

Risk

About This 510(k) Submission

K243478 is an FDA 510(k) clearance for the Straumann InLab Validated Workflow, 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 19, 2025, 103 days after receiving the submission on November 8, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K243478 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 2024
Decision Date	February 19, 2025
Days to Decision	103 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.