Cleared Traditional

K201051 - Straumann BoneCeramic

K201051 is the FDA 510(k) clearance for Straumann BoneCeramic by Institut Straumann AG. It is a Class 2 Dental device (product code LYC) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K201051 · Institut Straumann AG · Dental device
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Optimized for regulatory review, auditing and printing
Sep 2020
Decision
156d
Days
Class 2
Risk

K201051 is an FDA 510(k) clearance for the Straumann BoneCeramic. Classified as Bone Grafting Material, Synthetic (product code LYC), Class II - Special Controls.

Submitted by Institut Straumann AG (Basel, CH). The FDA issued a Cleared decision on September 24, 2020 after a review of 156 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - 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 K201051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2020
Decision Date September 24, 2020
Days to Decision 156 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
29d slower than avg
Panel avg: 127d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LYC Bone Grafting Material, Synthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Synthetic Bone Grafting Material Is Synthetically-derived Device, Such As Hydroxylapatite, Intended To Fill, Augment, Or Reconstruct Periodontal And Or Bony Defects Of The Upper Or Lower Jaw.
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 - LYC Bone Grafting Material, Synthetic

All 42
Devices cleared under the same product code (LYC) and FDA review panel - the closest regulatory comparables to K201051.
CMFlexTM
K213260 · Dimension Inx Corp. · Dec 2022
InRoad® Dental Synthetic Bone Graft
K202675 · Osteogene Tech Corp · Mar 2022
OsOpia Synthetic Bone Void Filler
K201546 · Revisios BV · Oct 2020
Cytrans Granules
K192597 · GC America, Inc. · Aug 2020
MASTERGRAFT PUTTY
K140374 · Medtronic Sofamor Danek USA, Inc. · Jun 2014
HEALOS DENTAL BONE GRAFT SUBSTITUTE (ALSO CALLED HEALOS OR HEALOS II) MODEL 6008, 6025
K093390 · Depuy Spine, Inc. · May 2010