FineEtch

Basic Information

• Brand Name: FineEtch
• Primary DI: 08809262954036
• Version / Model: 101-1201
• Catalog Number: 101-1201
• Company Name: Spident Co., Ltd.
• Labeler DUNS: 689370711
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-20
• Public Version: 8
• Public Version Date: 2025-10-09
• Public Version Status: Update
• Public Device Record Key: 7e991e25-4ea3-45a7-89c2-e539bb77777a

Device Description

37% Phosphoric Acid with semi-gel consistency for controlled contact.

Device Characteristics

• Single Use: No
• 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: Yes
• 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
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36153	Dental tooth-etching solution	An acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08809262954036	GS1
Package	20200101161714	GS1		100	Not in Commercial Distribution	2019-05-16
Package	00202202110178	GS1		200	Not in Commercial Distribution	2021-01-25
Package	00194202309204	GS1		180	Not in Commercial Distribution	2023-09-20

Customer Contacts

• Phone: [phone]
• Email: [email protected]