EDGE ENDO EAPEXSC

GUDID 00810988031237

EDGE APEX SILICONE COVERS

HANDPIECE PARTS & REPAIRS, INC.

Dental surgical power tool motorized handpiece/set, electric

• Primary Device ID: 00810988031237
• NIH Device Record Key: 8bb013cc-3441-4203-b781-9b47b3d490b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EDGE ENDO
• Version Model Number: EAPEXSC
• Catalog Number: EAPEXSC
• Company DUNS: 079723355
• Company Name: HANDPIECE PARTS & REPAIRS, INC.
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810988031237 [Unit of Use]
GS1	10810988031234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203320

FDA Product Code

• EKX: Handpiece, Direct Drive, Ac-Powered

Sterilization

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

[00810988031237]

Moist Heat or Steam Sterilization

[00810988031237]

Moist Heat or Steam Sterilization

[00810988031237]

Moist Heat or Steam Sterilization

[00810988031237]

Moist Heat or Steam Sterilization

[00810988031237]

Moist Heat or Steam Sterilization

[00810988031237]

Moist Heat or Steam Sterilization

[00810988031237]

Moist Heat or Steam Sterilization

[00810988031237]

Moist Heat or Steam Sterilization

[00810988031237]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-21
• Device Publish Date: 2022-07-13

On-Brand Devices [EDGE ENDO]

• 00810988031190: EDGE APEX MEASURING WIRE
• 00810988031183: EDGE APEX CONTRA ANGLE
• 00810988031169: EDGE APEX CORDLESS ENDODONTIC HANDPIECE
• 00810988031237: EDGE APEX SILICONE COVERS
• 00810988031213: EDGE APEX LIP HOOKS
• 00810988031206: EDGE APEX FILE CLIPS
• 00810988031220: EDGE APEX TOUCH PROBE
• 00810988031299: EdgeApex Apex Locator
• 00810988031329: EdgeApex File Clips (5 pack)
• 00810988031305: EdgeApex Lip Hooks (5 Pack)
• 00810988031633: EdgeFlow E25G-NR Injection needle
• 00810988031626: EdgeFlow E23G-NR Injection needle
• 00810988031619: EdgeFlow E20G-NR Injection needle
• 00810988031602: EdgeFlow E25G-L Injection needle
• 00810988031596: EdgeFlow E25G-M Injection needle
• 00810988031589: EdgeFlow E23G-L Injection needle
• 00810988031572: EdgeFlow E23G-M Injection needle
• 00810988031565: EdgeFlow E20G-L Injection needle
• 00810988031558: EdgeFlow E20G-M Injection needle
• 00810988031541: EdgeFlow E20G-S Injection needle
• 00810988031497: EdgeFlow Obturation Unit
• 00810988031480: EdgePack 6012 Tip
• 00810988031473: EdgePack 5508L Tip
• 00810988031466: EdgePack 5510 Tip
• 00810988031459: EdgePack 5508 Tip
• 00810988031442: EdgePack 5506 Tip
• 00810988031435: EdgePack 5004 Tip
• 00810988031428: EdgePack 4504 Tip
• 00810988031411: EdgePack 4004 Tip
• 00810988031404: EdgePack 3504 Tip
• 00810988031374: EdgePack Downpack Unit
• 00810988031350: EdgeApex Tester
• 00810988031336: EdgeApex Measuring Wire
• 00810988031312: EdgeApex Measuring File