enCore Night Guard

Primary DI
00860015217745
Brand
enCore Night Guard
Company
ENCORE LABORATORY LLC
Model
Putty - OTC
Published
2026-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
SHIImpression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SHIImpression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-CounterDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251926000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251926000enCore Impression MaterialEncore Guards2026-03-17SHI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015217745PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015217745008600152177458600152177450860015217745

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material kit, single-useA collection of non-sterile devices designed to obtain a negative imprint of the teeth and/or upper palate (i.e., the roof of the mouth with the gums and teeth). It is subsequently used to make a mould for the manufacture of a custom-made dental prosthesis, orthodontic appliance, and/or oral appliance. The kit typically includes dental impression materials and a dental impression tray(s); reusable application devices are not included. Impression material is placed on the tray and the tray is then positioned in the mouth of the patient until the material becomes firm creating the mould. This is a single-use device.

Regulatory Flags#

DUNS number
128114843
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015217721enCore Night GuardHard2026-03-02
00860015217738enCore Night GuardSoft2026-03-02
00860015217707enCore Night GuardHybrid2026-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013500726Remi Impression KitGrindGuard Inc.SHI2026-03-02