Cleared Abbreviated

K170207 - Obturys

K170207 is an FDA 510(k) clearance for Obturys, manufactured by Itena Clinical. The device is a Class 2 Dental device with product code KIF cleared through the Abbreviated 510(k) pathway after a 188-day FDA review.

K170207 · Itena Clinical · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
188d
Days
Class 2
Risk

K170207 is an FDA 510(k) clearance for the Obturys. Classified as Resin, Root Canal Filling (product code KIF), Class II - Special Controls.

Submitted by Itena Clinical (Paris, FR). The FDA issued a Cleared decision on July 31, 2017 after a review of 188 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3820 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K170207

510(k) Number K170207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2017
Decision Date July 31, 2017
Days to Decision 188 days
Submission Type Abbreviated
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
60d slower than avg
Panel avg: 128d · This submission: 188d
Pathway characteristics
Standards-based clearance path.

KIF Device Classification - Class 2, Special Controls

Product Code KIF Resin, Root Canal Filling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3820
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 Consultant

Lok North America, Inc.
Me Louis-Paul Marin

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 - KIF Resin, Root Canal Filling

All 141
Devices cleared under the same product code (KIF) and FDA review panel - the closest regulatory comparables to K170207.
ENDOSOLV
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K161239 · Avalon Biomed, Inc. · Sep 2016
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K151047 · Angelus Industria DE Productos Odontologicos · Aug 2016