Ormco™ EtchFree Bonding

Basic Information

• Brand Name: Ormco™ EtchFree Bonding
• Primary DI: 00889989088885
• Version / Model: 740-0500
• Company Name: ORMCO CORPORATION
• Labeler DUNS: 154614119
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2025-05-09
• Public Version: 2
• Public Version Date: 2025-10-09
• Public Version Status: Update
• Public Device Record Key: 424f3df0-462b-47b9-8788-ccf4387c21aa

Device Description

ORMCO ETCHFREE BONDING PRIMER, SINGLE PATIENT VIALS REFILL

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: No
• 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
DYH	ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN	Dental	872.3750	2

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
Unit of Use	10889989088882	GS1
Primary	00889989088885	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	0.6	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 60 – 80 Degrees Fahrenheit