Cleared Traditional

K162482 - A.B. DENTAL DEVICES Dental Implants System

K162482 is an FDA 510(k) clearance for A.B. DENTAL DEVICES Dental Implants System, manufactured by A.B. Dental Device , Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 374-day FDA review.

K162482 · A.B. Dental Device , Ltd. · Dental device
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Sep 2017
Decision
374d
Days
Class 2
Risk

K162482 is an FDA 510(k) clearance for the A.B. DENTAL DEVICES Dental Implants System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by A.B. Dental Device , Ltd. (Ashdod, IL). The FDA issued a Cleared decision on September 15, 2017 after a review of 374 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 A.B. Dental Device , Ltd. devices

FDA 510(k) Submission Details - K162482

510(k) Number K162482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2016
Decision Date September 15, 2017
Days to Decision 374 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
246d slower than avg
Panel avg: 128d · This submission: 374d
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 Consultant

Hogan Lovells US LLP
John Smith

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1375
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K162482.
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