Cleared Traditional

K163088 - TSIII BA Fixture

K163088 is the FDA 510(k) clearance for TSIII BA Fixture by Osstem Implant Co., Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K163088 · Osstem Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
168d
Days
Class 2
Risk

K163088 is an FDA 510(k) clearance for the TSIII BA Fixture. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Osstem Implant Co., Ltd. (Busan, KR). The FDA issued a Cleared decision on April 21, 2017 after a review of 168 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 K163088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2016
Decision Date April 21, 2017
Days to Decision 168 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
41d slower than avg
Panel avg: 127d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 422
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