Zekrya Gingival Protector Kit

Basic Information

• Brand Name: Zekrya Gingival Protector Kit
• Primary DI: D033003610961
• Version / Model: 003-61096
• Catalog Number: 003-61096
• Company Name: DMG AMERICA, LLC
• Labeler DUNS: 106792427
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-12
• Public Version: 1
• Public Version Date: 2022-12-20
• Public Version Status: New
• Public Device Record Key: 8d967ba8-a5f6-4dc1-8608-4fb7ae4de479

Device Description

Zekrya Gingival Protector

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BRW	Protector, Dental	Anesthesiology	868.5820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16352	Gingival retraction kit	A collection of sterile dental instruments and other items used to hold off the gingiva during abutment preparation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D033003610961	HIBCC

Customer Contacts

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