Cleared Traditional

K140021 - TI-OSS

K140021 is an FDA 510(k) clearance for TI-OSS, manufactured by Chiyewon. The device is a Class 2 Dental device with product code NPM cleared through the Traditional 510(k) pathway after a 518-day FDA review.

K140021 · Chiyewon · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
518d
Days
Class 2
Risk

K140021 is an FDA 510(k) clearance for the TI-OSS. Classified as Bone Grafting Material, Animal Source (product code NPM), Class II - Special Controls.

Submitted by Chiyewon (Los Angeles, US). The FDA issued a Cleared decision on June 5, 2015 after a review of 518 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3930 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Chiyewon devices

FDA 510(k) Submission Details - K140021

510(k) Number K140021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2014
Decision Date June 05, 2015
Days to Decision 518 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
391d slower than avg
Panel avg: 127d · This submission: 518d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NPM Device Classification - Class 2, Special Controls

Product Code NPM Bone Grafting Material, Animal Source
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3930
Definition A Animal-source Bone Grafting Material Is A Naturally-derived Device, Such As Collagen, Intended To Fill, Augment, Or Reconstruct Periodontal Defects And Or Bony Defects Of The Upper Or Lower Jaw.
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 - NPM Bone Grafting Material, Animal Source

All 25
Devices cleared under the same product code (NPM) and FDA review panel - the closest regulatory comparables to K140021.
Anorganic Bone Mineral in Delivery Applicator
K170541 · Collagen Matrix, Inc. · Jul 2017
Porcine Anorganic Bone Mineral in Delivery Applicator
K162158 · Collagen Matrix, Inc. · Feb 2017
A-Oss
K151542 · Hiossen, Inc. · Aug 2016
PORCINE ANORGANIC BONE MINERAL
K140714 · Collagen Matrix, Inc. · Jul 2014
GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC
K122894 · Geistlich Pharma AG · Feb 2013
GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O
K120601 · Geistlich Pharma AG · May 2012