Air-Driven Dental Handpieces

GUDID 00880027301133

MDK CO., LTD.

Dental surgical power tool motorized handpiece/set, pneumatic

• Primary Device ID: 00880027301133
• NIH Device Record Key: 79badc86-b204-44ac-a48b-d9d25a7e8b30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Air-Driven Dental Handpieces
• Version Model Number: 260i-M4
• Company DUNS: 695235237
• Company Name: MDK CO., LTD.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880027301133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141886

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[00880027301133]

Moist Heat or Steam Sterilization

[00880027301133]

Moist Heat or Steam Sterilization

[00880027301133]

Moist Heat or Steam Sterilization

[00880027301133]

Moist Heat or Steam Sterilization

[00880027301133]

Moist Heat or Steam Sterilization

[00880027301133]

Moist Heat or Steam Sterilization

[00880027301133]

Moist Heat or Steam Sterilization

[00880027301133]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-08
• Device Publish Date: 2022-11-30

On-Brand Devices [Air-Driven Dental Handpieces]

• 00880027301317: MOKO K45M-L
• 00880027301300: MOKO 420MT-L
• 00880027301294: MOKO 430MT-L
• 00880027301256: 260i-LED
• 00880027301188: MOKO TN45N LED
• 00880027301164: 260E-M4
• 00880027301133: 260i-M4
• 00880027301072: MOKO K45M
• 00880027301027: MOKO 760N LED pediatric
• 00880027301010: MOKO 760K LED pediatric
• 00880027300976: MD-4i
• 00880027300969: MD-4
• 00880027300891: CA-20Pi
• 00880027300884: CA-20P
• 00880027300860: CA-20L
• 00880027300846: FG-PL15
• 00880027300839: CA-PL30
• 00880027300815: CA-PL1
• 00880027300785: MOKO TN45K LED
• 00880027300716: MOKO 450M
• 00880027300693: MOKO 440M
• 00880027300679: MOKO 430M
• 00880027300655: MOKO 430MT
• 00880027300631: MOKO 420MT
• 00880027300617: MOKO 420M
• 00880027300426: MOKO 550N
• 00880027300419: MOKO 550K
• 00880027300327: MOKO 750N
• 00880027300310: MOKO 750K
• 00880027300174: MOKO 520S LED
• 00880027300167: MOKO 520K LED
• 00880027300150: MOKO 560N LED
• 00880027300129: MOKO 560S LED
• 00880027300112: MOKO 560K LED
• 00880027300075: MOKO 720S LED
• 00880027300068: MOKO 720K LED
• 00880027300051: MOKO 760N LED
• 00880027300020: MOKO 760S LED
• 00880027300013: MOKO 760K LED