510(k) clearances

Daybreak Impression Material

Sleepcare, LLC · Dental

K262421Substantially EquivalentTraditionalSHI
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Third party flag
N
City
Los Angeles
Advisory committee description
Dental
Address 1
11858 La Grange Ave. Floor 2
Statement or summary
Summary
Product code
SHI
Zip code
90025
Applicant
Sleepcare, LLC
Decision date
2026-10-20
Decision code
SESE
Country code
US
Device name
Daybreak Impression Material
Advisory committee
DE
Contact
Eliane Schaefer
K number
K262421
State
CA
Date received
2026-07-16
Review advisory committee
DE
Postal code
90025
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
Medical specialty description
Dental
Regulation number
872.3660
Device class
2
Registration number
3017575849, 3031288631, 3020749939
FEI number
3017575849, 3031288631, 3020749939
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.