Cleared Traditional

K111978 - SULCUS BLUE

K111978 · Produits Dentaires Pierre Rolland · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
93d
Days
-
Risk

K111978 is an FDA 510(k) clearance for the SULCUS BLUE. Classified as Cord, Retraction (product code MVL).

Submitted by Produits Dentaires Pierre Rolland (Mt. Laurel, US). The FDA issued a Cleared decision on October 13, 2011 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. 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. Standard predicate reliance. 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 Produits Dentaires Pierre Rolland devices

FDA 510(k) Submission Details - K111978

510(k) Number K111978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2011
Decision Date October 13, 2011
Days to Decision 93 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 127d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

MVL Device Classification - Class 0,

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

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