Cleared Traditional

K082573 - SARGON NON-EXPANDABLE DENTAL IMPLANT

K082573 is an FDA 510(k) clearance for SARGON NON-EXPANDABLE DENTAL IMPLANT, manufactured by Sargon Ent., Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 684-day FDA review.

K082573 · Sargon Ent., Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
684d
Days
Class 2
Risk

K082573 is an FDA 510(k) clearance for the SARGON NON-EXPANDABLE DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sargon Ent., Inc. (Washington, US). The FDA issued a Cleared decision on July 21, 2010 after a review of 684 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.

FDA 510(k) Submission Details - K082573

510(k) Number K082573 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2008
Decision Date July 21, 2010
Days to Decision 684 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
556d slower than avg
Panel avg: 128d · This submission: 684d
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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K082573.
NEODENT IMPLANT SYSTEM
K101207 · Jjgc Industria E Comercio DE Materiais Dentarios S · Aug 2010
VARIOUS DENTAL IMPLANTS
K100411 · Grundy Advanced Biomedical Systems, LLC · Jul 2010
DEFCON TSA/TSH DENTAL IMPLANT SYSTEM
K092261 · Impladent, S.L. · Jul 2010
COTEC DENTAL IMPLANT SYSTEM
K100511 · Cotec Implant Co., Ltd. · Jul 2010
AEDIS(TM)
K100902 · Embed Technology, LLC · Jun 2010
BIODENTA DENTAL IMPLANT SYSTEM
K093630 · Biodenta Swiss AG · Jun 2010
K082573 · SARGON NON-EXPANDABLE DENTAL IMPLANT
Download PDF FDA Summary Sargon Ent., Inc.