Cleared Traditional

K081751 - ADIN DENTAL IMPLANTS SYSTEM

K081751 is an FDA 510(k) clearance for ADIN DENTAL IMPLANTS SYSTEM, manufactured by Adin Dental Implants System, Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K081751 · Adin Dental Implants System, Ltd. · Dental device
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Dec 2008
Decision
183d
Days
Class 2
Risk

K081751 is an FDA 510(k) clearance for the ADIN DENTAL IMPLANTS SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Adin Dental Implants System, Ltd. (Mitzpe Aviv, IL). The FDA issued a Cleared decision on December 19, 2008 after a review of 183 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.

FDA 510(k) Submission Details - K081751

510(k) Number K081751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2008
Decision Date December 19, 2008
Days to Decision 183 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 128d · This submission: 183d
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 1499
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K081751.
CAMLOG IMPLANT SYSTEM MODIFIED IMPLANTS AND ABUTMENTS
K083496 · Altatec GmbH · Jan 2009
PITT-EASY DENTAL IMPLANT SYSTEM
K083297 · Sybron Implant Solutions GmbH · Jan 2009
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K082651 · Southern Implants, Inc. · Dec 2008
ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS
K082639 · Zimmer Dental, Inc. · Dec 2008
OMNI-TIGHT
K082749 · Basic Dental Implant Systems, Inc. · Dec 2008
KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5
K082200 · SOADCO, S.L. · Nov 2008
K081751 · ADIN DENTAL IMPLANTS SYSTEM
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