Cleared Traditional

K211419 - Gingi-Aid Gel (FDA 510(k) Clearance)

K211419 · Belport Company, Inc., Gingi-Pak · Dental device
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Jan 2022
Decision
248d
Days
-
Risk

K211419 is an FDA 510(k) clearance for the Gingi-Aid Gel. Classified as Cord, Retraction (product code MVL).

Submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on January 10, 2022 after a review of 248 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 Belport Company, Inc., Gingi-Pak devices

Submission Details

510(k) Number K211419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2021
Decision Date January 10, 2022
Days to Decision 248 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
121d slower than avg
Panel avg: 127d · This submission: 248d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -