Cleared Traditional

K111364 - HAPTITE COATING IMPLANT SYSTEM

K111364 is the FDA 510(k) clearance for HAPTITE COATING IMPLANT SYSTEM by Dentis Co., Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K111364 · Dentis Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
261d
Days
Class 2
Risk

K111364 is an FDA 510(k) clearance for the HAPTITE COATING IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dentis Co., Ltd. (Brea, US). The FDA issued a Cleared decision on February 1, 2012 after a review of 261 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 Dentis Co., Ltd. devices

Submission Details

510(k) Number K111364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2011
Decision Date February 01, 2012
Days to Decision 261 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
134d slower than avg
Panel avg: 127d · This submission: 261d
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 581
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K111364.
ZIMMER DENTAL TAPERED SCREW-VENT X
K113753 · Zimmer Dental, Inc. · Aug 2012
ET/SS IMPLANT SYSTEM
K120847 · Osstem Implant Co., Ltd. · Aug 2012
BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM
K121131 · Straumann USA · Jun 2012
TAPERED SCREW-VENT X IMPLANT
K112160 · Zimmer Dental, Inc. · Dec 2011
ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT
K111889 · Zimmer Dental, Inc. · Dec 2011
STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM
K111357 · Straumann USA · Oct 2011