Cleared Traditional

K260661 - Midas Restore (FDA 510(k) Clearance)

K260661 · Sprintray, Inc. · Dental device
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Apr 2026
Decision
44d
Days
-
Risk

K260661 is an FDA 510(k) clearance for the Midas Restore.

Submitted by Sprintray, Inc. (Los Angeles, US). The FDA issued a Cleared decision on April 15, 2026 after a review of 44 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 Sprintray, Inc. devices

Submission Details

510(k) Number K260661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2026
Decision Date April 15, 2026
Days to Decision 44 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
83d faster than avg
Panel avg: 127d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -