Cleared Traditional

K213742 - Infinity Pro, Logic, Quality, Sprint (FDA 510(k) Clearance)

Class I Dental device.

K213742 · Olsen Ind?stria E Com?rcio S.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
324d
Days
Class 1
Risk

K213742 is an FDA 510(k) clearance for the Infinity Pro, Logic, Quality, Sprint. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Olsen Ind?stria E Com?rcio S.A. (Palhoça, BR). The FDA issued a Cleared decision on October 19, 2022 after a review of 324 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Olsen Ind?stria E Com?rcio S.A. devices

Submission Details

510(k) Number K213742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2021
Decision Date October 19, 2022
Days to Decision 324 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
197d slower than avg
Panel avg: 127d · This submission: 324d
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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