Cleared Traditional

V-Print splint (K201091) - FDA 510(k) Clearance

K201091 · Voco GmbH · Dental device
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Nov 2020
Decision
197d
Days
-
Risk

K201091 is an FDA 510(k) clearance for the V-Print splint. Classified as Mouthguard, Prescription (product code MQC).

Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on November 6, 2020 after a review of 197 days - an extended review 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: 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.

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Submission Details

510(k) Number K201091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2020
Decision Date November 06, 2020
Days to Decision 197 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
70d slower than avg
Panel avg: 127d · This submission: 197d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Peers - MQC Mouthguard, Prescription

All 70
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