Calamus

Basic Information

• Brand Name: Calamus
• Primary DI: D716CALSHLD1
• Version / Model: CALSHLD
• Catalog Number: CALSHLD
• Company Name: TULSA DENTAL PRODUCTS LLC
• Labeler DUNS: 942778564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2022-10-18
• Public Version: 1
• Public Version Date: 2022-10-26
• Public Version Status: New
• Public Device Record Key: 0b2b2396-ba35-49d8-a690-71678874fe44

Device Description

Cal Flow Heat Shield Refill

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: 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
EKR	PLUGGER, ROOT CANAL, ENDODONTIC	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47750	Warm-bonded endodontic obturation system	An assembly of devices designed to deliver preheated resin-based sealing, filling, and core materials into a root canal for direct warm bonding during an endodontic obturation procedure. It typically consists of a mains electricity (AC-powered) oven used to heat the preloaded oburators, a series of root canal sizers (verifiers) used for the selection of the appropriate obturator, and preloaded obturators; other materials may be included (e.g., self-etch sealer).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D716CALSHLD0	HIBCC
Primary	D716CALSHLD1	HIBCC