Cleared Traditional

Ti-one 101 TS Dental Implant System (K172821) - FDA 510(k) Clearance

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

K172821 · Hung Chun Bio-S Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
266d
Days
Class 2
Risk

K172821 is an FDA 510(k) clearance for the Ti-one 101 TS Dental Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Hung Chun Bio-S Co., Ltd. (Kaohsiung, TW). The FDA issued a Cleared decision on June 11, 2018 after a review of 266 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 Hung Chun Bio-S Co., Ltd. devices

Submission Details

510(k) Number K172821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2017
Decision Date June 11, 2018
Days to Decision 266 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
139d slower than avg
Panel avg: 127d · This submission: 266d
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 Peers - DZE Implant, Endosseous, Root-form

All 302
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K172821.
KJ ZIRCONIA Implant System
K173116 · Kj Meditech Co., Ltd. · Jun 2018
MIS Internal Hex Dental Implant System
K180282 · Mis Implants Technologies , Ltd. · Jun 2018
IU Implant System
K172345 · Warantec Co., Ltd. · Jun 2018
Piccolo Implants and Accessories
K173706 · Southern Implants (Pty), Ltd. · Jun 2018
Straumann BLX Implant System
K173961 · Institut Straumann AG · Jun 2018
UF(II) Wide Fixture
K173975 · Dio Corporation · Jun 2018