EdgeApex HP™ EAPEXSC

GUDID 10818365028204

EdgeApex HP Protective Silicone Cover (3 pack)

US ENDODONTICS, LLC

Dental surgical power tool motorized handpiece/set, electric

• Primary Device ID: 10818365028204
• NIH Device Record Key: d7f5240e-f91e-49c7-b623-831938dd5d5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeApex HP™
• Version Model Number: EAPEXSC
• Catalog Number: EAPEXSC
• Company DUNS: 061317427
• Company Name: US ENDODONTICS, LLC
• Device Count: 3
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com
• Phone: +1(423)283-0047
• Email: Bobby.bennett@us-endo.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818365028207 [Primary]
GS1	10818365028204 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203320

FDA Product Code

• EKX: Handpiece, direct drive, ac-powered

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: 2023-07-03
• Device Publish Date: 2023-06-25

On-Brand Devices [EdgeApex HP™]

• 10818365029010: EdgeApex HP Lip Hook (5 pack)
• 00818365028221: EdgeApex HP Touch Probe
• 00818365028214: EdgeApex HP Spray Nozzle
• 10818365028204: EdgeApex HP Protective Silicone Cover (3 pack)
• 00818365028191: EdgeApex HP O-Ring
• 00818365028184: EdgeApex HP Measuring Wire
• 10818365028167: EdgeApex HP File Clip (5 pack)
• 00818365028153: EdgeApex HP Contra Angle
• 00818365028146: EdgeApex HP Charging Base
• 00818365028139: EdgeApex HP Adapter
• 00818365028122: EdgeApex HP