FDA.reportPublic FDA data

Harvest EasyGum

Primary DI
D87097941
Brand
Harvest EasyGum
Company
Harvest Dental Products, LLC
Model
9794
Catalog number
9794
Device description
OnX x EasyGum Trial Kit
Published
2026-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231389000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231389000Harvest Dental HD Gum StripHarvest Dental Products, LLC2023-08-16EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D87097941PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
794668751
Device count
1
Kit
true
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
D87097961Harvest EasyGum979697962026-01-20
D87010035161Harvest Esthetic DCL Denture10035-1610035-162025-10-27
D87010035201Harvest Esthetic DCL Denture10035-2010035-202025-10-27
D87010035251Harvest Esthetic DCL Denture10035-2510035-252025-10-27
D870980011EasyGum Strip 980098002024-10-03
D87098401EasyGum Strip - Modifier984098402024-09-10
D87098421EasyGum Strip - Modifier984298422024-09-10
D87098441EasyGum Strip - Modifier984498442024-09-10
D87098461EasyGum Strip - Modifier984698462024-09-10
D87098481EasyGum Strip - Modifier984898482024-09-10
D87098501EasyGum Strip - Modifier985098502024-09-10
D87098521EasyGum Strip - Modifier985298522024-09-10
D87098541EasyGum Strip - Modifier985498522024-09-10
D87098561EasyGum Strip - Modifier985698562024-09-10
D87098581EasyGum Strip - Modifier985898582024-09-10
D87098601EasyGum Strip - Modifier986098602024-09-10
D87097972EasyGum Strip979797972024-07-23
D870980426EasyGum Strip980498042024-07-23
D870980628EasyGum Strip980698062024-07-23
D87098082EasyGum Strip980898082024-07-23

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07615208585810IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
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