Manufacturer registered with FDA

Sleep Science Partners, Inc.

Larkspur, CA, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator10023348Specification developer
Device types listed
1
Brands and models
3
510(k) clearances
22012–2019
Markets registered in
1United States
Establishments
1United States
2012: 12019: 120102020

510(k) clearances per year, 2007–2026

Devices listed with FDA

What Sleep Science Partners, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Anti-Snoring DeviceLRK · Class 2Anti-snoring & jaw-repositioning devicesMaker
PureSleepPureSleep (OTC)PureSleep Pro
2007

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Sleep Science Partners, Inc. as the applicant.

Decided510(k)DeviceDevice type
11 Apr 2019K190058PureSleep (OTC use)LRK Anti-Snoring Device
11 Jun 2012K113022PURESLEEPLRK Anti-Snoring Device

Also lists devices cleared under other names

Sleep Science Partners, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.

Original applicants: D.D.S., Inc. (1).

Decided510(k)DeviceApplicantDevice type
2 Oct 1995K954128SNOREMASTERD.D.S., Inc.LRK Anti-Snoring Device

Registered establishments

EstablishmentLocationWhat it does
Sleep Science Partners, Inc.FDA reg. 3006794225Larkspur, CA, United StatesSpecification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10023348). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.