Cleared Traditional

K201561 - Membrane Screws and Membrane Tacks

K201561 is the FDA 510(k) clearance for Membrane Screws and Membrane Tacks by Neoss Limited. It is a Class 2 Dental device (product code DZL) cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K201561 · Neoss Limited · Dental device
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Oct 2020
Decision
117d
Days
Class 2
Risk

K201561 is an FDA 510(k) clearance for the Membrane Screws and Membrane Tacks. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Neoss Limited (Harrogate, GB). The FDA issued a Cleared decision on October 5, 2020 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - 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 Neoss Limited devices

Submission Details

510(k) Number K201561 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2020
Decision Date October 05, 2020
Days to Decision 117 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
10d faster than avg
Panel avg: 127d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZL Screw, Fixation, Intraosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4880
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

Msquared Associates, Inc.
Cherita James

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 - DZL Screw, Fixation, Intraosseous

All 41
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K201561.
Stryker MP, Mandible, HMMF and MMF AXS Screws
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K222367 · Dentis Co., Ltd. · Mar 2023
The Micro Screw System, Micro Screw System Basic
K201210 · Hager& Meisinger GmbH · Oct 2021
Bone Screw, Bone Tack
K182881 · Osstem Implant Co., Ltd. · Aug 2019
OssBuilder System
K181854 · Osstem Implant Co., Ltd. · May 2019
J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030
K101902 · Jeil Medical Corporation · Feb 2011