Cleared Traditional

K182609 - Delphos Implants Rigid Fixation System

K182609 is the FDA 510(k) clearance for Delphos Implants Rigid Fixation System by Delphos Implants - Ind.Com. Importacao E Exportacao DE. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K182609 · Delphos Implants - Ind.Com. Importacao E Exportacao DE · Dental device
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Mar 2019
Decision
189d
Days
Class 2
Risk

K182609 is an FDA 510(k) clearance for the Delphos Implants Rigid Fixation System. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Delphos Implants - Ind.Com. Importacao E Exportacao DE (Armazem. No5 Cascais, PT). The FDA issued a Cleared decision on March 29, 2019 after a review of 189 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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 Delphos Implants - Ind.Com. Importacao E Exportacao DE devices

Submission Details

510(k) Number K182609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2018
Decision Date March 29, 2019
Days to Decision 189 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
62d slower than avg
Panel avg: 127d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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

Passarini Regulatory Affairs of America, LLC
Mauro Malzyner

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 - JEY Plate, Bone

All 156
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