FDA.reportPublic FDA data

enCore Night Guard

Primary DI
00860015217707
Brand
enCore Night Guard
Company
ENCORE LABORATORY LLC
Model
Hybrid
Published
2026-01-08
Public version status
Update
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU
OBRMouthguard, Over-The-CounterUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015217707PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015217707008600152177078600152177070860015217707

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
128114843
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
00860015217745enCore Night GuardPutty - OTC2026-04-14
00860015217721enCore Night GuardHard2026-03-02
00860015217738enCore Night GuardSoft2026-03-02

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00651080651523PlackersRANIR, LLCOBR2024-04-26
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H66841101411KeyPrintKeystone IndustriesMQC2023-09-25
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