Device
Hydrostatic occlusal splint, Aqualizer assembly, Ultra Low
Manufacturer
Jumar Corporation
Jumar Corporation
Model: Ultra Low
Catalog: AQ-102
DI: 00860013921125
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-04
Current Version: 2026-05-12
Description
Hydrostatic occlusal splint, Aqualizer assembly, Ultra Low
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
13212b97-6030-49c2-aff8-4b1797fc1e43
Distribution Status:
In Commercial Distribution
DUNS Number:
047438079
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860013921125
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 36311
Name: Removable dental occlusal splint, preformed
Definition:
A 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.
FDA Product Codes
KMY
Positioner, Tooth, Preformed
Premarket Submissions
Submission Number:
K831793
Supplement Number:
000
Environmental Conditions
Storage Handling - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Unit:
Degrees Celsius
Storage Handling - Storage Handling High - @attributes - Value:
22
Storage Handling - Storage Handling Type:
Storage Environment Temperature