FDA.reportPublic FDA data

Custom Night Guard

Primary DI
00860013500733
Brand
Custom Night Guard
Company
GrindGuard Inc.
Model
1
Device description
Custom Hard Night Guard
Published
2026-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MQCMouthguard, Prescription
OBRMouthguard, Over-The-Counter
OCOMouthguard, Migraine/Tension Headache

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU
OBRMouthguard, Over-The-CounterUnknownU
OCOMouthguard, Migraine/Tension HeadacheUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013500733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013500733008600135007338600135007330860013500733

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made mouthguardA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117870267
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013500740Custom Night Guard12026-03-05
00860013500726Remi Impression Kit12026-03-02
00860013500702Custom Night Guard12025-03-17

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00651080651523PlackersRANIR, LLCOBR2024-04-26
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