Cleared Traditional

K213149 - VOCO Retraction Paste (FDA 510(k) Clearance)

K213149 · Voco GmbH · Dental device
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Dec 2021
Decision
73d
Days
-
Risk

K213149 is an FDA 510(k) clearance for the VOCO Retraction Paste. Classified as Cord, Retraction (product code MVL).

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on December 9, 2021 after a review of 73 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.

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Submission Details

510(k) Number K213149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2021
Decision Date December 09, 2021
Days to Decision 73 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
54d faster than avg
Panel avg: 127d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -