Cleared Traditional

K083670 - UNIVERSAL

K083670 is an FDA 510(k) clearance for UNIVERSAL, manufactured by Euroteknika. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K083670 · Euroteknika · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
224d
Days
Class 2
Risk

K083670 is an FDA 510(k) clearance for the UNIVERSAL, AESTHETICA, NATEA, NATURA. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Euroteknika (Montreal, Quebec, CA). The FDA issued a Cleared decision on July 23, 2009 after a review of 224 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 Euroteknika devices

FDA 510(k) Submission Details - K083670

510(k) Number K083670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2008
Decision Date July 23, 2009
Days to Decision 224 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
97d slower than avg
Panel avg: 127d · This submission: 224d
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 789
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K083670.
HG III FIXTURE SYSTEM
K093352 · Hiossen, Inc. · Nov 2009
ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX
K092594 · Ace Surgical Supply Co., Inc. · Sep 2009
SPI DENTAL IMPLANT INICELL
K090154 · Thommen Medical AG · Jul 2009
MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM
K082843 · Dentis Co., Ltd. · Jun 2009
HS II SHORT FIXTURE SYSTEM
K083633 · Osstem Implant Co., Ltd. · May 2009
I-FIX SYSTEM
K083586 · Dentis Co., Ltd. · Apr 2009