Maxima 5704225

GUDID 00304040189641

Maxima Core 1:1 Optic Straight Electric Attachment

HENRY SCHEIN, INC.

Dental power tool handpiece motorless component

• Primary Device ID: 00304040189641
• NIH Device Record Key: ec4a298c-bb3c-4a28-9631-b5d2fb63b3ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maxima
• Version Model Number: 5704225
• Catalog Number: 5704225
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• Serial Number: true
• 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	00304040189641 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192809

FDA Product Code

• EFA: Handpiece, belt and/or gear driven, dental

Sterilization

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

[00304040189641]

Moist Heat or Steam Sterilization

[00304040189641]

Moist Heat or Steam Sterilization

[00304040189641]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-22
• Device Publish Date: 2025-01-14

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• 00304040189641: Maxima Core 1:1 Optic Straight Electric Attachment