Cleared Traditional

K190552 - JJ Implant System

K190552 is the FDA 510(k) clearance for JJ Implant System by Jj Implants. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K190552 · Jj Implants · Dental device
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Optimized for regulatory review, auditing and printing
Dec 2019
Decision
276d
Days
Class 2
Risk

K190552 is an FDA 510(k) clearance for the JJ Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Jj Implants (Chalakudy, IN). The FDA issued a Cleared decision on December 6, 2019 after a review of 276 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 Jj Implants devices

Submission Details

510(k) Number K190552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2019
Decision Date December 06, 2019
Days to Decision 276 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
149d slower than avg
Panel avg: 127d · This submission: 276d
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
Kevin A. Thomas

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 611
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K190552.
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