FDA.reportPublic FDA data

Aqualizer

Primary DI
00860013921125
Brand
Aqualizer
Company
Jumar Corporation
Model
Ultra Low
Catalog number
AQ-102
Device description
Hydrostatic occlusal splint, Aqualizer assembly, Ultra Low
Published
2026-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
KMYPositioner, Tooth, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K831793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K831793000AQUALIZER MOUTHPIECEMartin D. Lerman1983-08-12KMY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013921125PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013921125008600139211258600139211250860013921125

GMDN Terms#

Term, Definition table
TermDefinition
Removable dental occlusal splint, preformedA rigid or flexible prefabricated device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporo-mandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is removable by the patient (e.g., during meals), and is typically made of standard, preformed materials that are not moulded, or intended to be moulded to a specific patient. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius22 Degrees Celsius

Regulatory Flags#

DUNS number
047438079
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013921118AqualizerUltra HighAQ-1012026-05-04
00860013921132AqualizerSlim MediumAQ-1042026-05-04
00860013921149AqualizerSlim HighAQ-1052026-05-04
00860013921156AqualizerSlim LowAQ-1062026-05-04
00860013921163AqualizerMini MediumAQ-1082026-05-04
00860013921170AqualizerMini HighAQ-1092026-05-04
00860013921187AqualizerMini LowAQ-1102026-05-04
00860013921101AqualizerUltra MediumAQ-1002026-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054154160013EQUILIBRATORE 1.0EPTAMED SRLKMY2026-07-28
08054154160020EQUILIBRATORE 1.05EPTAMED SRLKMY2026-07-28
08054154160037EQUILIBRATORE 1.1EPTAMED SRLKMY2026-07-28
08054154160051EQUILIBRATORE 1.2 YOUNGEPTAMED SRLKMY2026-07-28
08054154160143EQUILIBRATORE 3.2EPTAMED SRLKMY2026-07-28
08054154160150EQULIBRATORE 3.3EPTAMED SRLKMY2026-07-28
08054154160198EquiIlibratore C2EPTAMED SRLKMY2026-07-28
08054154160204Equilibratore C3EPTAMED SRLKMY2026-07-28
08054154160211Equilibratore C4EPTAMED SRLKMY2026-07-28
08054154160228EQUILIBRATORE C3PEPTAMED SRLKMY2026-07-28
08054154160259EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160266EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160273EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160297FREEDOMEPTAMED SRLKMY2026-07-28
08054154160303EQUILIBRATORE GENIUS 3EPTAMED SRLKMY2026-07-28
08054154160334EQUILIBRATORE NIKI 1EPTAMED SRLKMY2026-07-28
08054154160372EQUILIBRATORE 003EPTAMED SRLKMY2026-07-28
08054154160402EQUILIBRATORE SL3 YOUNGEPTAMED SRLKMY2026-07-28
08054154160426EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154160433EQUILIBRATORE U4EPTAMED SRLKMY2026-07-28
08054154160501EQULIBRATORE U2EPTAMED SRLKMY2026-07-28
08054154160563EQUILIBRATORE GENIUSEPTAMED SRLKMY2026-07-28
08054154160761EQUILIBRATORE NIKI 2EPTAMED SRLKMY2026-07-28
08054154160815EQUILIBRATORE GENIUSEPTAMED SRLKMY2026-07-28
08054154160822EQUILIBRATORE GENIUS 2EPTAMED SRLKMY2026-07-28
08054154160945EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154160969EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154161089EQULIBRATORE 1.1EPTAMED SRLKMY2026-07-28
08054154161126EQUILIBRATORE C3P YOUNGEPTAMED SRLKMY2026-07-28
08054154161164EQULIBRATORE U4 YOUNGEPTAMED SRLKMY2026-07-28