Manufacturer registered with FDA
Siesta Medical, Inc.
Los Gatos, CA, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 10 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 102010–2021
- Markets registered in
- 310 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Siesta Medical, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Siesta Medical, Inc. | 10 clearances | 2010–2021 | Below |
| Colombia | INVIMA | Registration holder | SIESTA MEDICAL INC | 8 | — | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Siesta Medical, Inc. | 2 | 2016–2016 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Siesta Medical, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Tongue Suspension SystemORY · Class 2 | — | Maker | Encore System | 2024 |
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 Siesta Medical, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 22 Dec 2021 | K213159 | Encore System | ORY Tongue Suspension System |
| 2 Oct 2020 | K201238 | Encore System | ORY Tongue Suspension System |
| 9 May 2019 | K183310 | Encore System | ORY Tongue Suspension System |
| 26 Mar 2014 | K133680 | ENCORE SYSTEM | ORY Tongue Suspension System |
| 6 Dec 2012 | K121440 | ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KIT | ORY Tongue Suspension System |
| 7 Nov 2012 | K121814 | ENCORE TONGUE SUSPENSION SYSTEM | ORY Tongue Suspension System |
| 1 Jul 2011 | K111179 | ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMEN | ORY Tongue Suspension System |
| 8 Apr 2011 | K110127 | PRELUDE III TONGUE SUSPENSION SYSTEM | ORY Tongue Suspension System |
| 20 Dec 2010 | K103179 | PRELUDE II TOUNGE SUSPENSION SYSTEM | ORY Tongue Suspension System |
| 8 Jul 2010 | K101060 | SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEM | ORY Tongue Suspension System |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SIESTA MEDICAL, INC.FDA reg. 3008792120 | Los Gatos, CA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10033959). 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.