Cleared Traditional

K111364 - HAPTITE COATING IMPLANT SYSTEM

K111364 is an FDA 510(k) clearance for HAPTITE COATING IMPLANT SYSTEM, manufactured by Dentis Co., Ltd.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K111364

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.

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 1173
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K111364.
UNIVERSAL MAXILLARY MOLAR
K110337 · Oco Biomedical · Mar 2012
KAT IMPLANTS SYSTEM ONE-PIECE IMPLANTS 2.5X10
K112758 · Kat Implants, LLC · Feb 2012
S-MINI IMPLANT SYSTEM
K112540 · Neobiotech Co., Ltd. · Feb 2012
BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMS
K112875 · Blue Sky Bio, LLC · Jan 2012
SLIM ONEBODY SYSTEM
K111162 · Dentium Co., Ltd. · Jan 2012
TAPERED SCREW-VENT X IMPLANT
K112160 · Zimmer Dental, Inc. · Dec 2011