SLEEPCARE, LLC

FDA Device Registration & Listing · Los Angeles, CA, US · Registration 3031288631

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3031288631
FEI Number
3031288631
Entity Name
SLEEPCARE, LLC
City/State/Country
Los Angeles, CA, US
Establishment Address
11858 La Grange Ave Fl 2, Los Angeles, CA 90025, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Sleepcare, LLC (Owner Number: 10090819)
Owner / Operator Contact Address
11858 La Grange Ave, 2nd FL, Los Angeles, CA 90025, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K201483
PMA Number
N/A

All Registered Proprietary Names

Daybreak Device Classic Daybreak Impression Material Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LRK Device, Anti-Snoring Dental Class 2 872.5570 2024-05-21
ELW Material, Impression Dental Class 2 872.3660 2026-06-18

Official Correspondent

Eliane Schaefer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sleepcare, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K122391 Medtronic Xomed, Inc. MEDTRONIC XOMED, INC. 2013-01-10
K952614 Dentsply Intl. JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL 1996-08-13

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031288631. Last updated year: 2026. Please use registration number 3031288631 when referencing this establishment in official correspondence.
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