Spirapost

Basic Information

• Brand Name: Spirapost
• Primary DI: D0338881001
• Version / Model: 888100
• Catalog Number: 888100
• Company Name: DMG AMERICA, LLC
• Labeler DUNS: 106792427
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-09
• Public Version: 1
• Public Version Date: 2022-12-19
• Public Version Status: New
• Public Device Record Key: d0eb8c51-da5e-45f7-911f-056812512634

Device Description

Spirapost PFS Introductory Package (10 Tapered Posts, 10 Parallel Posts, 1 #4 Gates Glidden, 1 #5 Gates Glidden and 1 Spirapost Ruler)

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
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	D0338881001	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K060075	000