Cleared Traditional

K103810 - KJ SUBMERGED SYSTEM

K103810 is an FDA 510(k) clearance for KJ SUBMERGED SYSTEM, manufactured by Kj Meditech Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K103810 · Kj Meditech Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
259d
Days
Class 2
Risk

K103810 is an FDA 510(k) clearance for the KJ SUBMERGED SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Kj Meditech Co., Ltd. (Fullerton, US). The FDA issued a Cleared decision on September 14, 2011 after a review of 259 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 Kj Meditech Co., Ltd. devices

FDA 510(k) Submission Details - K103810

510(k) Number K103810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2010
Decision Date September 14, 2011
Days to Decision 259 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
132d slower than avg
Panel avg: 127d · This submission: 259d
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 797
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K103810.
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
ET III SA ULTRA WIDE SYSTEM
K103537 · Hiossen, Inc. · Mar 2011
INCLUSIVE MINI IMPLANT
K100932 · Prismatik Dentalcraft, Inc. · Dec 2010
NOBEL ACTIVE 3.0
K102436 · Nobel Biocare AB · Dec 2010