Cleared Traditional

K161197 - Orthodontic Screw

K161197 is the FDA 510(k) clearance for Orthodontic Screw by Osstem Implant Co., Ltd.. It is a Class 2 Dental device (product code OAT) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K161197 · Osstem Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
237d
Days
Class 2
Risk

K161197 is an FDA 510(k) clearance for the Orthodontic Screw. Classified as Implant, Endosseous, Orthodontic (product code OAT), Class II - Special Controls.

Submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on December 21, 2016 after a review of 237 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 K161197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2016
Decision Date December 21, 2016
Days to Decision 237 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
110d slower than avg
Panel avg: 127d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAT Implant, Endosseous, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
Definition It Is Intended To Provide A Fixed Anchorage Point For Attachment Of Orthodontic Appliances To Facilitate The Orthodontic Movement Of Teeth. It Is Used Temporarily And Is Removed After Orthodontic Treatment Has Been Completed.
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

Hiossen, Inc.
DAVID KIM

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 - OAT Implant, Endosseous, Orthodontic

All 21
Devices cleared under the same product code (OAT) and FDA review panel - the closest regulatory comparables to K161197.
BIO-RAY A-1 Anchor Screw System
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ORTHODONTIC SCREW
K103105 · Osstem Implant Co., Ltd. · Mar 2011
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K093299 · Synthes (Usa) · Dec 2010
SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM
K063473 · Synthes (Usa) · Mar 2007