Verge

GUDID D915K21062

Stainless Steel K File Size 6 Length 21

Plastcare USA

Manual endodontic file/rasp, reusable

• Primary Device ID: D915K21062
• NIH Device Record Key: 20a1b951-4d66-4b6f-b816-bf306a6d97fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Verge
• Version Model Number: K2106
• Company DUNS: 079299604
• Company Name: Plastcare USA
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D915K21060 [Unit of Use]
HIBCC	D915K21061 [Primary]
HIBCC	D915K21062 [Package]; Contains: D915K21061; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-18
• Device Publish Date: 2020-03-10

Devices Manufactured by Plastcare USA

• D915WHW2 - Plastcare: 2020-05-11 Saliva Ejector White with White Tip
• D915MBK22 - Sentinel: 2020-05-06 Earloop Mask - Black ASTM Level 2
• D915MBL22 - Sentinel: 2020-05-06 Earloop Mask - Blue ASTM Level 2
• D915MPI22 - Sentinel: 2020-05-06 Earloop Mask - Pink ASTM Level 2
• D915MWH22 - Sentinel: 2020-05-06 Earloop Mask - White ASTM Level 2
• D915RIT50152 - Plastcare: 2020-03-19 5oz Disposable Plastic Dental Cup Pink
• D915RIT50202 - Plastcare: 2020-03-19 5oz Disposable Plastic Dental Cup Green
• D915RIT50252 - Plastcare: 2020-03-19 5oz Disposable Plastic Dental Cup White