Transluma Intro. Post Kit

Basic Information

• Brand Name: Transluma Intro. Post Kit
• Primary DI: D757G91620K1
• Version / Model: G-91620K
• Catalog Number: G-91620K
• Company Name: BISCO INC.
• Labeler DUNS: 053529939
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-06
• Public Version: 3
• Public Version Date: 2020-09-25
• Public Version Status: Update
• Public Device Record Key: 27143a3e-c5a7-43f6-b89c-50b2a76aa920
• Distribution End Date: 2020-02-10

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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DZA	DRILL, DENTAL, INTRAORAL	Dental	872.4130	1
ELR	POST, ROOT CANAL	Dental	872.3810	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45650	Root canal post kit	A collection of dental devices intended for use during insertion of a root canal post(s), sometimes with core build-up. This device typically includes a prefabricated root canal post(s), drill(s), thread cutter, and may include core-build-up materials such as applicator (dispensing gun), dental composite resin(s), dentine bonding agent, and etching solution. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D757G91620K1	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			sixe text