DT Post Placement Kit

Basic Information

• Brand Name: DT Post Placement Kit
• Primary DI: D757G91730K1
• Version / Model: G-91730K
• Catalog Number: G-91730K
• Company Name: BISCO INC.
• Labeler DUNS: 053529939
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-12
• Public Version: 4
• Public Version Date: 2022-06-06
• Public Version Status: Update
• Public Device Record Key: 837c1ab6-705f-4a27-83b2-c5ddb3cad943
• Distribution End Date: 2020-02-18

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMA	CEMENT, DENTAL	Dental	872.3275	2
DZA	DRILL, DENTAL, INTRAORAL	Dental	872.4130	1
KXR	APPLICATOR, RESIN	Dental	872.3140	1
ELR	POST, ROOT CANAL	Dental	872.3810	1
KLE	AGENT, TOOTH BONDING, RESIN	Dental	872.3200	2
EBF	MATERIAL, TOOTH SHADE, RESIN	Dental	872.3690	2
EID	SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL	Dental	872.4565	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	D757G91730K1	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			sixe text

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius