Cleared Traditional

K180924 - Reflect Implant System

K180924 is the FDA 510(k) clearance for Reflect Implant System by Ids - Integrated Dental Systems. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 354-day FDA review.

K180924 · Ids - Integrated Dental Systems · Dental device
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Mar 2019
Decision
354d
Days
Class 2
Risk

K180924 is an FDA 510(k) clearance for the Reflect Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Ids - Integrated Dental Systems (Englewood Cliffs, US). The FDA issued a Cleared decision on March 29, 2019 after a review of 354 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 Ids - Integrated Dental Systems devices

Submission Details

510(k) Number K180924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2018
Decision Date March 29, 2019
Days to Decision 354 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
227d slower than avg
Panel avg: 127d · This submission: 354d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

PaxMed International, LLC
Floyd Larson

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 645
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K180924.
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