EsTemp C&B

Basic Information

• Brand Name: EsTemp C&B
• Primary DI: 08809262953756
• Version / Model: Hexa-Temp AO3
• Catalog Number: #1204AO3
• Company Name: Spident Co., Ltd.
• Labeler DUNS: 689370711
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-20
• Public Version: 1
• Public Version Date: 2026-04-28
• Public Version Status: New
• Public Device Record Key: b92dea2e-9dae-4cde-b70a-889a7348116f

Device Description

Hexa-Temp is temporary crown and bridge resin that is used temporarily before repairing a permanent restoration. It can be self-cured resin. Filler size ranges from 0.7 to 1.2 µm, resulting in good radio-opacity and high flexural strength.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809262953756	GS1