Cleared Traditional

K130140 - INTRA-LOCK OP DENTAL IMPLANT

K130140 is an FDA 510(k) clearance for INTRA-LOCK OP DENTAL IMPLANT, manufactured by Intra-Lock International. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K130140 · Intra-Lock International · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
191d
Days
Class 2
Risk

K130140 is an FDA 510(k) clearance for the INTRA-LOCK OP DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Intra-Lock International (Boca Raton, US). The FDA issued a Cleared decision on August 1, 2013 after a review of 191 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 Intra-Lock International devices

FDA 510(k) Submission Details - K130140

510(k) Number K130140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2013
Decision Date August 01, 2013
Days to Decision 191 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
64d slower than avg
Panel avg: 127d · This submission: 191d
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 864
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K130140.
ZIMMER DENTAL TRABECULAR METAL IMPLANT SYSTEM
K132258 · Zimmer Dental, Inc. · Nov 2013
LEGACY3 6MM LENGTH IMPLANTS
K131097 · Implant Direct Sybron Manufacturing, LLC · Aug 2013
ANYONETM INTERNAL IMPLANT SYSTEM
K123988 · Megagen Implant Co., Ltd. · Aug 2013
ETII SA FIXTURE SYSTEM
K123471 · Hiossen, Inc. · Jul 2013
STRAUMANN DENTAL IMPLANT SYSTEM
K130222 · Straumann USA, LLC · Apr 2013
STRAUMANN DENTAL IMPLANT SYSTEM
K123784 · Straumann USA, LLC · Apr 2013