K251908 - Emanate Tray

K251908 is an FDA 510(k) clearance for the Emanate Tray. Classified as Oral Wound Dressing (product code OLR).

Submitted by Emanate Biomedical (New York, US). The FDA issued a Cleared decision on July 29, 2026 after a review of 404 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

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