Cleared Traditional

Straumann Variobase Abutments XC for Bridge/Bar

K253315 · Institut Straumann AG · Dental

Jan 2026

Decision

114d

Days

Class 2

Risk

About This 510(k) Submission

K253315 is an FDA 510(k) clearance for the Straumann Variobase Abutments XC for Bridge/Bar, 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 January 22, 2026, 114 days after receiving the submission on September 30, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.3630.

Submission Details

510(k) Number	K253315 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 30, 2025
Decision Date	January 22, 2026
Days to Decision	114 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.