Cleared Traditional

K222604 - dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S (FDA 510(k) Clearance)

K222604 · Dentona AG · Dental device
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Optimized for regulatory review, auditing and printing
Apr 2023
Decision
235d
Days
-
Risk

K222604 is an FDA 510(k) clearance for the dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memospli.... Classified as Mouthguard, Prescription (product code MQC).

Submitted by Dentona AG (Dortmund, DE). The FDA issued a Cleared decision on April 21, 2023 after a review of 235 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.

View all Dentona AG devices

Submission Details

510(k) Number K222604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2022
Decision Date April 21, 2023
Days to Decision 235 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
108d slower than avg
Panel avg: 127d · This submission: 235d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQC Mouthguard, Prescription
Device Class -

Regulatory Consultant

Apf Consulting
Andreas Foerster

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 - MQC Mouthguard, Prescription

All 70
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