Cleared Traditional

K222836 - Straumann Variobase Abutments and Strau...

K222836 is the FDA 510(k) clearance for Straumann Variobase Abutments and Strau... by Institut Straumann AG. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K222836 · Institut Straumann AG · Dental device
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May 2023
Decision
237d
Days
Class 2
Risk

K222836 is an FDA 510(k) clearance for the Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs. 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 Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on May 15, 2023 after a review of 237 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Institut Straumann AG devices

Submission Details

510(k) Number K222836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2022
Decision Date May 15, 2023
Days to Decision 237 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 127d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Straumann USA, LLC
Jennifer M. Jackson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K222836.
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K230246 · Dentis Co., Ltd. · May 2023
SIMDA Abutment
K223663 · Simda Co., Ltd. · May 2023
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K230523 · Dentis Co., Ltd. · May 2023
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K221969 · Warantec Co., Ltd. · May 2023
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K230203 · Dentis Co., Ltd. · May 2023
ET Abutment System
K222636 · Hiossen, Inc. · Apr 2023