Cleared Traditional

K082843 - MODIFICATON TO: DENTIS DENTAL IMPLANT S...

K082843 is the FDA 510(k) clearance for MODIFICATON TO: DENTIS DENTAL IMPLANT S... by Dentis Co., Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K082843 · Dentis Co., Ltd. · Dental device
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Jun 2009
Decision
263d
Days
Class 2
Risk

K082843 is an FDA 510(k) clearance for the MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dentis Co., Ltd. (Santa Fe Springs, US). The FDA issued a Cleared decision on June 19, 2009 after a review of 263 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 K082843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2008
Decision Date June 19, 2009
Days to Decision 263 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
136d slower than avg
Panel avg: 127d · This submission: 263d
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 K082843.
HG II SHORT FIXTURE SYSTEM
K091678 · Osstem Implant Co., Ltd. · Feb 2010
STRAUMANN RC TEMPORARY ABUTMENTS
K093027 · Straumann USA · Feb 2010
3.25 SPLINE TWIST IMPLANT, HA COATED
K093164 · Zimmer Dental, Inc. · Dec 2009
HS II SHORT FIXTURE SYSTEM
K083633 · Osstem Implant Co., Ltd. · May 2009
I-FIX SYSTEM
K083586 · Dentis Co., Ltd. · Apr 2009
STRAUMANN DENTAL IMPLANT SYSTEM
K083550 · Straumann USA · Feb 2009