Air-Driven Dental Handpieces

GUDID 00880027300327

MDK CO., LTD.

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Primary Device ID	00880027300327
NIH Device Record Key	6b0e1cde-fbdf-40ae-94e4-06043228c9ad
Commercial Distribution Status	In Commercial Distribution
Brand Name	Air-Driven Dental Handpieces
Version Model Number	MOKO 750N
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	00880027300327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K141886

FDA Product Code

EFB	Handpiece, Air-Powered, Dental