Model: MYO-001
DI: 00860015852106
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
Segmented Anatomical Intraoral Device
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d2ac28c8-8282-45c2-8e4b-bb6a3145fd25
Distribution Status:
In Commercial Distribution
DUNS Number:
018000231
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860015852106
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 43025
Name: Removable dental occlusal splint, custom-made
Definition:
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.
FDA Product Codes
MQC
Mouthguard, Prescription
OCO
Mouthguard, Migraine/Tension Headache
Premarket Submissions
Submission Number:
K230548
Supplement Number:
000