Cleared Traditional

K100356 - TDS PRECISION DENTAL BAR

K100356 is an FDA 510(k) clearance for TDS PRECISION DENTAL BAR, manufactured by Pou YU Biotechnology Co., Ltd.. The device is a Class 2 Dental device with product code NHA cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K100356 · Pou YU Biotechnology Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
235d
Days
Class 2
Risk

K100356 is an FDA 510(k) clearance for the TDS PRECISION DENTAL BAR. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Pou YU Biotechnology Co., Ltd. (Fusing Township, Changhua Cty, TW). The FDA issued a Cleared decision on October 5, 2010 after a review of 235 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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.

FDA 510(k) Submission Details - K100356

510(k) Number K100356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 2010
Decision Date October 05, 2010
Days to Decision 235 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
107d slower than avg
Panel avg: 128d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 715
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K100356.
SFI-BAR IMPLANT ADAPTER STRAUMANN, SFI-BAR IMPLANT ADAPTER FOR NEOSS IMPLANT
K102382 · Cendres & Metaux SA · Dec 2010
CAM STRUCTSURE BARS
K101582 · Biomet 3i, Inc. · Nov 2010
SIRONA CAD/CAM SYSTEM
K100152 · Sirona Dental Systems GmbH · Oct 2010
BIOHORIZONS SIMPLE SOLUTIONS WITH LASER-LOK
K100985 · BioHorizons Implant Systems, Inc. · Sep 2010
NOBELPROCERA TI ABUTMENT THOMMEN PLATFORMS
K101714 · Nobel Biocare AB · Aug 2010
ACCUFIT DENTAL IMPLANT ABUTMENTS & SCREWS
K101068 · Radiant Express, LLC · Aug 2010
K100356 · TDS PRECISION DENTAL BAR
Download PDF FDA Summary Pou YU Biotechnology …