Cleared Traditional

K180935 - Infinity / Infinity Cross Flex Dental S...

K180935 is the FDA 510(k) clearance for Infinity / Infinity Cross Flex Dental S... by Olsen Industria E Comercio S.A.. It is a Class 1 Dental device (product code EIA) cleared through the Traditional 510(k) pathway after a 666-day FDA review.

K180935 · Olsen Industria E Comercio S.A. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

Regulatory Peers - EIA Unit, Operative Dental

All 60
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K180935.
Perceptive electric dental motor and control unit
K220873 · Lares Research · Dec 2022
Infinity Pro, Logic, Quality, Sprint
K213742 · Olsen Ind?stria E Com?rcio S.A. · Oct 2022
A-dec 300, A-dec 500
K213932 · A-Dec, Inc. · Mar 2022
K3
K183347 · Osstem Implant Co., Ltd. · Sep 2019
Qraypen
K183121 · AIOBIO Co., Ltd. · Jul 2019
Forest Dental Unit
K173608 · Forest Dental Products, Inc. · Aug 2018