Cleared Traditional

The Micro Screw System, Micro Screw System Basic (K201210) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201210 · Hager& Meisinger GmbH · Dental device
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Oct 2021
Decision
521d
Days
Class 2
Risk

K201210 is an FDA 510(k) clearance for the The Micro Screw System, Micro Screw System Basic. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Hager& Meisinger GmbH (Neuss, DE). The FDA issued a Cleared decision on October 8, 2021 after a review of 521 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Hager& Meisinger GmbH devices

Submission Details

510(k) Number K201210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2020
Decision Date October 08, 2021
Days to Decision 521 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
394d slower than avg
Panel avg: 127d · This submission: 521d
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 Peers - DZL Screw, Fixation, Intraosseous

All 30
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K201210.
KLS Martin Drill-Free MMF Screw
K233721 · KLS-Martin L.P. · Sep 2024
Stryker MP, Mandible, HMMF and MMF AXS Screws
K231599 · Stryker Leibinger GmbH & Co KG · Aug 2023
SAVE GBR
K222367 · Dentis Co., Ltd. · Mar 2023
Membrane Screws and Membrane Tacks
K201561 · Neoss Limited · Oct 2020
Bone Screw, Bone Tack
K182881 · Osstem Implant Co., Ltd. · Aug 2019
OssBuilder System
K181854 · Osstem Implant Co., Ltd. · May 2019