Device
Custom-fit thermoplastic dental night guard for protection against teeth grinding (bruxism) during sleep. Single-user, multi-use, boil-and-bite molded for individual fit. Over-the-...
Manufacturer
LATE NIGHT CONCEPTS, INC
LATE NIGHT CONCEPTS, INC
Model: BR-102
Catalog: BNG
DI: 00860003090411
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-20
Current Version: 2026-05-28
Description
Custom-fit thermoplastic dental night guard for protection against teeth grinding (bruxism) during sleep. Single-user, multi-use, boil-and-bite molded for individual fit. Over-the-counter.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2a559d18-2ccb-46dd-b762-0097334960e9
Distribution Status:
In Commercial Distribution
DUNS Number:
080973935
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:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860003090411
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 46493
Name: Removable dental occlusal splint, customizable
Definition:
A device intended for home-use 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 plastic materials and can be softened, typically in hot water, and moulded over the teeth by the user to provide an anatomical fit (customizable). This is a reusable device.
FDA Product Codes
MQC
Mouthguard, Prescription
Premarket Submissions
Submission Number:
K181361
Supplement Number:
000