Cleared Traditional

Infinity / Infinity Cross Flex Dental Systems (K180935) - FDA 510(k) Clearance

Class I Dental device.

K180935 · Olsen Industria E Comercio S.A. · Dental device
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Feb 2020
Decision
666d
Days
Class 1
Risk

K180935 is an FDA 510(k) clearance for the Infinity / Infinity Cross Flex Dental Systems. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Olsen Industria E Comercio S.A. (Palhoça -, BR). The FDA issued a Cleared decision on February 5, 2020 after a review of 666 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Olsen Industria E Comercio S.A. devices

Submission Details

510(k) Number K180935 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2018
Decision Date February 05, 2020
Days to Decision 666 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
539d slower than avg
Panel avg: 127d · This submission: 666d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Techlink International
Lilian Llull

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.

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