Cleared Traditional

K192913 - R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose (FDA 510(k) Clearance)

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

K192913 · Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · Dental device
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Jan 2021
Decision
462d
Days
Class 2
Risk

K192913 is an FDA 510(k) clearance for the R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose. Classified as Agent, Tooth Bonding, Resin (product code KLE), Class II - Special Controls.

Submitted by Imicryl Dis Malzemeleri Sanayi VE Ticaret AS (Konya, TR). The FDA issued a Cleared decision on January 19, 2021 after a review of 462 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3200 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Imicryl Dis Malzemeleri Sanayi VE Ticaret AS devices

Submission Details

510(k) Number K192913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2019
Decision Date January 19, 2021
Days to Decision 462 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
335d slower than avg
Panel avg: 127d · This submission: 462d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLE Agent, Tooth Bonding, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3200
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 - KLE Agent, Tooth Bonding, Resin

All 417
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