Cleared Traditional

K182881 - Bone Screw

K182881 is the FDA 510(k) clearance for Bone Screw by Osstem Implant Co., Ltd.. It is a Class 2 Dental device (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

Submission Details

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.

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 41
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
J TAC MODEL JT-MD-035, JT-MD-040, JT-MD-045, JT-CL-030
K101902 · Jeil Medical Corporation · Feb 2011
RAPIDSORB PLUS SCREW SYSTEM
K093464 · Synthes (Usa) · Jan 2010