DENTECH

Basic Information

• Brand Name: DENTECH
• Primary DI: 04560218661470
• Version / Model: 01030130
• Company Name: DENTECH CORPORATION
• Labeler DUNS: 700723000
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-24
• Public Version: 1
• Public Version Date: 2020-10-02
• Public Version Status: New
• Public Device Record Key: ac6b14c3-9a42-4e00-99c8-110bb412fdba

Device Description

Rubber Dam Starter Kit, Glossy. This set includes non-latex dental dam. So, we put "Yes" for Expiration Date. "For Single use", we put "No" by considering Rubber Dam Clamp and other stainless items in this set. But non-latex dental dam(included in this set) is for single use.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

GMDN Terms

Code	Name	Definition	Implantable	Status
45000	Rubber dam kit	A collection of devices used to apply and remove a rubber dam, which is created chairside and placed over the crown of a patient's tooth or teeth in order to eliminate saliva or to prevent the patient swallowing liquid/dental material during dental surgery. It typically consists of rubber dam material, clamps, forceps, punch, frame, and tray. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04560218661470	GS1