MK-dent Germany®

GUDID 04050546001326

MK-Dent GmbH

Dental power tool system handpiece, pneumatic

• Primary Device ID: 04050546001326
• NIH Device Record Key: 2618aa9d-de8f-41a8-9e29-fac820459ea5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MK-dent Germany®
• Version Model Number: HB23KL
• Company DUNS: 343618943
• Company Name: MK-Dent GmbH
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04050546001326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032234

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[04050546001326]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-09-24

On-Brand Devices [MK-dent Germany® ]

• 04050546151625: QC5016K
• 04050546151526: QC5015K
• 04050546141428: QC4014K
• 04050546003948: QC6016SW
• 04050546003931: QC6016NT
• 04050546003924: QC6016KW
• 04050546003917: QC6016K
• 04050546003887: QC5016W
• 04050546003863: QC5016NT
• 04050546003856: QC5016KW
• 04050546003849: QC5016S
• 04050546003825: QC4014W
• 04050546003818: QC4014NT
• 04050546003771: PR1011W
• 04050546003765: PR1011S
• 04050546003740: PR1011K
• 04050546003733: PR1011B
• 04050546003160: LCH11P
• 04050546003153: LPH21
• 04050546003146: LPH16
• 04050546003139: LPH11
• 04050546003122: LP74L
• 04050546003115: LP27L
• 04050546003108: LP11L
• 04050546003092: LP01L
• 04050546003085: LE74L
• 04050546003078: LE74
• 04050546003061: LE54L
• 04050546003054: LE54
• 04050546003047: LE27L
• 04050546003030: LE27
• 04050546003023: LE21L
• 04050546003016: LE21
• 04050546003009: LE16L
• 04050546002996: LE16
• 04050546002989: LE148L
• 04050546002972: LE148
• 04050546002965: LE11L
• 04050546002958: LE11
• 04050546002934: LE01
• 04050546002927: LCH21
• 04050546002910: LCH16
• 04050546002903: LCH11
• 04050546002859: LC11L
• 04050546002842: LC11
• 04050546002835: LC01L
• 04050546002828: LC01
• 04050546002804: LBH11P
• 04050546002798: LBH11C
• 04050546002781: LBH11