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510(k) K213159

Device
Encore System
Applicant
Siesta Medical, Inc.
510(k) number
K213159
Product code
ORY  
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-22
Date received
2021-09-28
Regulation
872.5570
Classification name
Prelude Tongue Suspension System
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Michael Kolber
Address
101 Church St. Los Gatos CA US 95030 95030

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ORY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K201238Encore SystemSiesta Medical, Inc.2020-10-02
K183310Encore SystemSiesta Medical, Inc.2019-05-09
K133680ENCORE SYSTEMSiesta Medical, Inc.2014-03-26
K121440ENCORE TONGUE SUSPENSION SYSTEM ENCORE REMOVAL-TITRATION KITSiesta Medical, Inc.2012-12-06
K121814ENCORE TONGUE SUSPENSION SYSTEMSiesta Medical, Inc.2012-11-07
K111179ENCORE TONGUE SUSPENSION SYSTEM (MONOFILAMENT #1 SUSPENSION SUTURE), ENCORE TONGUE SUSPENSION SYSTEM SYSTEM (MONOFILAMENSiesta Medical, Inc.2011-07-01
K110127PRELUDE III TONGUE SUSPENSION SYSTEMSiesta Medical, Inc.2011-04-08
K103179PRELUDE II TOUNGE SUSPENSION SYSTEMSiesta Medical, Inc.2010-12-20
K101060SIESTA MEDICAL, INC., PRELUDE TONGUE SUSPENSION SYSTEMSiesta Medical, Inc.2010-07-08

Legacy Summary#

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FDA Review#

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