Harvest Esthetic DCL Denture

Basic Information

• Brand Name: Harvest Esthetic DCL Denture
• Primary DI: D87010035201
• Version / Model: 10035-20
• Catalog Number: 10035-20
• Company Name: Harvest Dental Products, LLC
• Labeler DUNS: 794668751
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-10-27
• Public Version: 1
• Public Version Date: 2025-11-04
• Public Version Status: New
• Public Device Record Key: 5603f8db-f582-4fa8-8946-d35429e646a3

Device Description

CAD Tooth Polymer, Gradient - BL-3 98x20mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
EBG	Crown And Bridge, Temporary, Resin	Dental	872.3770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31783	Temporary dental crown/bridge	A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D87010035201	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K192153	000