Home GUDID 00860012026135 Daybreak
Primary DI 00860012026135
Brand Daybreak
Company Sleepcare LLC
Model Rise and Bite
Device description Morning repositioning device used after mandibular advancement device therapy
Published 2026-10-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name KMY Positioner, Tooth, Preformed
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KMY Positioner, Tooth, Preformed Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860012026135 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860012026135 00860012026135 860012026135 0860012026135
GMDN Terms# Term, Definition table Term Definition Removable dental occlusal splint, custom-made A rigid or flexible custom-made device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is removable by the patient (e.g., during meals), and is typically made of synthetic polymer materials and manufactured to meet the needs of an individual patient. This is a reusable device.
Regulatory Flags# DUNS number 119274056 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00860012026111 Daybreak Daybreak Device Classic silent-nite-device-v1 2026-10-19 00860012026142 Daybreak Daybreak Impression Kit 2026-10-19
Other Devices Sharing Product Codes#