Daybreak Impression Material— 510(k) K262421

Substantially Equivalent

Sleepcare, LLC

FDA 510(k) clearance K262421 for Daybreak Impression Material, Substantially Equivalent on 2026-10-20. Applicant: Sleepcare, LLC. Device class: 2.

Clearance details

Applicant
Sleepcare, LLC
Product code
Product code SHI
Device class
Class 2
Regulation
21 CFR 872.3660
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Los Angeles, CA, US
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