Owl Night Guard

Basic Information

• Brand Name: Owl Night Guard
• Primary DI: 00860014754609
• Version / Model: 1
• Company Name: OWL DENTAL LAB INC
• Labeler DUNS: 125242583
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-05
• Public Version: 1
• Public Version Date: 2026-03-13
• Public Version Status: New
• Public Device Record Key: 6ac29f8d-c5af-420c-bc2a-f4671a5120c7

Device Description

Owl Hybrid Night Guard

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQC	Mouthguard, Prescription	Unknown		U
OBR	Mouthguard, Over-The-Counter	Unknown		U
OCO	Mouthguard, Migraine/Tension Headache	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
38620	Custom-made mouthguard	A custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860014754609	GS1

Premarket Submissions

Submission Number	Supplement Number
K253641	000