Cleared Traditional

Vista Clear (K193389) - FDA 510(k) Clearance

K193389 · Inter-Med/Vista Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2020
Decision
89d
Days
-
Risk

K193389 is an FDA 510(k) clearance for the Vista Clear. Classified as Cord, Retraction (product code MVL).

Submitted by Inter-Med/Vista Dental Products (Racine, US). The FDA issued a Cleared decision on March 4, 2020 after a review of 89 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.

View all Inter-Med/Vista Dental Products devices

Submission Details

510(k) Number K193389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2019
Decision Date March 04, 2020
Days to Decision 89 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
38d faster than avg
Panel avg: 127d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 K193389.
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Stasis Gel
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Gingi-Aid Gel
K211419 · Belport Company, Inc., Gingi-Pak · Jan 2022
VOCO Retraction Paste
K213149 · Voco GmbH · Dec 2021