Cleared Traditional

K050180 - EXPA-SYL

K050180 · Produits Dentaires Pierre Rolland · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
16d
Days
-
Risk

K050180 is an FDA 510(k) clearance for the EXPA-SYL. Classified as Cord, Retraction (product code MVL).

Submitted by Produits Dentaires Pierre Rolland (Orange, US). The FDA issued a Cleared decision on February 11, 2005 after a review of 16 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K050180

510(k) Number K050180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2005
Decision Date February 11, 2005
Days to Decision 16 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
112d faster than avg
Panel avg: 128d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

MVL Device Classification - Class 0,

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 35
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K050180.
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K050180 · EXPA-SYL
Download PDF FDA Summary Produits Dentaires Pi…