Cleared Traditional

K182881 - Bone Screw, Bone Tack

K182881 is an FDA 510(k) clearance for Bone Screw, manufactured by Osstem Implant Co., Ltd.. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K182881 · Osstem Implant Co., Ltd. · Dental device
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Aug 2019
Decision
298d
Days
Class 2
Risk

K182881 is an FDA 510(k) clearance for the Bone Screw, Bone Tack. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on August 9, 2019 after a review of 298 days - an extended review cycle.

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 Osstem Implant Co., Ltd. devices

FDA 510(k) Submission Details - K182881

510(k) Number K182881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2018
Decision Date August 09, 2019
Days to Decision 298 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
171d slower than avg
Panel avg: 127d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZL Device Classification - Class 2, Special Controls

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 72
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K182881.
SAVE GBR
K222367 · Dentis Co., Ltd. · Mar 2023
The Micro Screw System, Micro Screw System Basic
K201210 · Hager& Meisinger GmbH · Oct 2021
Membrane Screws and Membrane Tacks
K201561 · Neoss Limited · Oct 2020
OssBuilder System
K181854 · Osstem Implant Co., Ltd. · May 2019
Intra-Lock Bone Fixation System
K171831 · Intra-Lock International, Inc. · Oct 2017
Salvin Tenting Screw System
K161857 · Salvin Dental Specialties · Apr 2017