Cleared Traditional

K182609 - Delphos Implants Rigid Fixation System (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182609 · Delphos Implants - Ind.Com. Importacao E Exportacao DE · Dental device
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.

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
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 158d · 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 Peers - JEY Plate, Bone

All 8
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