FDA.reportPublic FDA data

O2Vent Optima

Primary DI
09351567000363
Brand
O2Vent Optima
Company
OVENTUS MANUFACTURING PTY LTD
Model
O2Vent Optima Mini
Catalog number
O2VBM
Device description
The O2Vent OptimaMini is a removable medical device that is fitted in the patient’s mouth and is intended to reduce oralleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aidin the treatment of these conditions.
Published
2021-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LRKDevice, Anti-Snoring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190236000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190236000O2Vent OptimaOventus Manufacturing Pty, Ltd.2019-08-29LRK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09351567000363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09351567000363093515670003639351567000363

GMDN Terms#

Term, Definition table
TermDefinition
Mandible-repositioning sleep-disordered breathing orthosisA removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
748034696
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09351567000028O2Vent WO2Vent W2019-04-30
09351567000035O2Vent OptimaO2Vent Optima2020-01-03
09351567000004O2Vent Mono (OVENT)O2Vent Mono2019-05-30
09351567000011O2Vent TO2Vent T2019-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D775IBASA0Herbst -Banded Upper Or Lower-Single ArchGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBN0Bonded HerbstGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNE0Bonded Herbst - RPEGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNER0Bonded Herbst - RPE Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
D775IBNR0Bonded Herbst-Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-05-07
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESLRK2026-04-24
00860015650405EMADENTAL PROSTHETIC SERVICES, INC.LRK2026-04-17
00850077473760EMA AcrylicEMA SLEEP INCORPORATEDLRK2026-04-14
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00850077473784EMA CustomEMA SLEEP INCORPORATEDLRK2026-04-14
00850077473807EMA MilledEMA SLEEP INCORPORATEDLRK2026-04-14
D775IBA0Banded HerbstGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBABN0Bonded LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAE0Banded Herbst -RPEGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAEBN0Rpe Bonded LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAER0Banded Herbst-Rpe Remov LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IBAR0Banded Herbst -Removable LowerGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775IIST0Telescopic Herbst SleepGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
D775INIST0Nylon Herbst SleepGreat Lakes Dental Technologies, Ltd.LRK2026-04-13
00860014652103Itus MouthguardzShinrin-Yoku Traders LLCLRK2026-04-06
00860014652110Itus MouthguardzShinrin-Yoku Traders LLCLRK2026-04-06
00860014652127Itus MouthguardzShinrin-Yoku Traders LLCLRK2026-04-06
00850085577009Serena Fixed HingeSERENA SLEEP SOLUTIONS LLCLRK2026-03-30
D8410491E1TAP 3 EliteOrtho Solutions, LCLRK2026-02-25
D8418053R1Respire Blue+ HardOrtho Solutions, LCLRK2026-02-25
D8418054R1Respire Blue+ Hard/SoftOrtho Solutions, LCLRK2026-02-25
D8418056R1Respire Blue+ EFOrtho Solutions, LCLRK2026-02-25