DENTECH

Basic Information

• Brand Name: DENTECH
• Primary DI: 04560218669384
• Version / Model: 01014505
• 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: 402ba5d0-cf56-48d8-9fab-623fd15ec9e7

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EEF	Clamp, Rubber Dam	Dental	872.6300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15712	Rubber dam clamp	A dental device with a buccal and lingual wing, or flange, used to anchor a rubber dam down to the cervical region of an exposed tooth. This device comes in a variety of shapes, sizes, and designs for various situations. It is typically made of spring metal and has bevelled jaws that contact the tooth, and a bow that connects the jaws. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04560218669384	GS1