Medidenta PM-EM-EZ

GUDID 00850046903410

hygiene motor with quick disconnect feature

Medidenta

Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic Dental surgical power tool motorized handpiece/set, pneumatic

• Primary Device ID: 00850046903410
• NIH Device Record Key: fc41feb7-6c06-4735-8e9e-54978eb50c89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medidenta
• Version Model Number: PM-EM-EZ
• Catalog Number: PM-EM-EZ
• Company DUNS: 012401576
• Company Name: Medidenta
• Device Count: 1
• 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: 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	00850046903410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030603

FDA Product Code

• EGS: Handpiece, Contra- And Right-Angle Attachment, Dental

Sterilization

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

[00850046903410]

Moist Heat or Steam Sterilization

[00850046903410]

Moist Heat or Steam Sterilization

[00850046903410]

Moist Heat or Steam Sterilization

[00850046903410]

Moist Heat or Steam Sterilization

[00850046903410]

Moist Heat or Steam Sterilization

[00850046903410]

Moist Heat or Steam Sterilization

[00850046903410]

Moist Heat or Steam Sterilization

[00850046903410]

Moist Heat or Steam Sterilization

[00850046903410]

Moist Heat or Steam Sterilization

[00850046903410]

Moist Heat or Steam Sterilization

[00850046903410]

Moist Heat or Steam Sterilization

[00850046903410]

Moist Heat or Steam Sterilization

[00850046903410]

Moist Heat or Steam Sterilization

[00850046903410]

Moist Heat or Steam Sterilization

[00850046903410]

Moist Heat or Steam Sterilization

[00850046903410]

Moist Heat or Steam Sterilization

[00850046903410]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-22
• Device Publish Date: 2023-11-14

On-Brand Devices [Medidenta]

• 00850046903380: Convert Fixed 4-hole low-speed to a quick disconnect model ***Low Speeds Only***
• 00850046903373: second half connecting to the supply line (RED)
• 00850046903366: part connecting to the HP (BLUE)
• 00850046903427: motor & nose cone set
• 00850046903410: hygiene motor with quick disconnect feature