Cleared Traditional

K071803 - ARDS DENTAL IMPLANTS

K071803 is an FDA 510(k) clearance for ARDS DENTAL IMPLANTS, manufactured by Ards, Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 431-day FDA review.

K071803 · Ards, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
431d
Days
Class 2
Risk

K071803 is an FDA 510(k) clearance for the ARDS DENTAL IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Ards, Ltd. (Somerset, US). The FDA issued a Cleared decision on September 5, 2008 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Ards, Ltd. devices

FDA 510(k) Submission Details - K071803

510(k) Number K071803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date September 05, 2008
Days to Decision 431 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
304d slower than avg
Panel avg: 127d · This submission: 431d
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 939
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K071803.
TEMPORARY TOOTH REPLACEMENT
K081900 · Ormco Corp. · Oct 2008
GS III FIXTURE SYSTEM
K082213 · Osstem Implant Co., Ltd. · Oct 2008
MDI MII ONE-PIECE IMPLANT, 2.9MM
K081653 · Imtec Corp. · Sep 2008
MS SYSTEM (NARROW RIDGE)
K080594 · Osstem Implant Co., Ltd. · Sep 2008
RESCUE EXTERNAL IMPLANT SYSTEM
K081302 · Megagen Implant Co., Ltd. · Aug 2008
HG II FIXTURE SYSTEM
K080744 · Osstem Implant Co., Ltd. · Jul 2008