Cleared Traditional

K101096 - HT III SA FIXTURE SYSTEM

K101096 is an FDA 510(k) clearance for HT III SA FIXTURE SYSTEM, manufactured by Hiossen, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K101096 · Hiossen, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
171d
Days
Class 2
Risk

K101096 is an FDA 510(k) clearance for the HT III SA FIXTURE SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Hiossen, Inc. (Fariless Hills, US). The FDA issued a Cleared decision on October 8, 2010 after a review of 171 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 Hiossen, Inc. devices

FDA 510(k) Submission Details - K101096

510(k) Number K101096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2010
Decision Date October 08, 2010
Days to Decision 171 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
44d slower than avg
Panel avg: 127d · This submission: 171d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

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 1185
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K101096.
NOBEL ACTIVE 3.0
K102436 · Nobel Biocare AB · Dec 2010
GC AADVA IMPLANT SYSTEM
K093749 · GC America, Inc. · Dec 2010
SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS
K102308 · Dentium Co., Ltd. · Nov 2010
TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT
K101880 · Zimmer Dental, Inc. · Oct 2010
TAPERED SCREW-VENT T IMPLANT
K101977 · Zimmer Dental, Inc. · Sep 2010
MODIFICATION TO: HG III ULTRA WIDE SYSTEM
K093889 · Hiossen, Inc. · Apr 2010