DENTECH

Basic Information

• Brand Name: DENTECH
• Primary DI: 04560218661197
• Version / Model: 01021011
• 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: 0403c578-a079-45f7-b551-9d8653cc619b

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
EJG	Forceps, Rubber Dam Clamp	Dental	872.6300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35553	Rubber dam punch	A hand-held dental instrument used to place holes in rubber dam material to permit the passage of the dam over the crowns of the teeth. The handles are squeezed together and the plunger (punch) creates a hole in the rubber dam material. It is typically designed to create various hole sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04560218661197	GS1