MD 30

GUDID ENOU3330IMP0

Dental implant motor system

Nouvag AG

Remotely-driven dental drilling system motor

• Primary Device ID: ENOU3330IMP0
• NIH Device Record Key: 4d9405dc-e7e0-4d99-ae4b-389a99f42a5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MD 30
• Version Model Number: 3330IMP
• Company DUNS: 480610476
• Company Name: Nouvag AG
• 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
HIBCC	ENOU3330IMP0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042434

FDA Product Code

• DZI: Drill, Bone, Powered

Sterilization

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

[ENOU3330IMP0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-01
• Device Publish Date: 2018-08-31

On-Brand Devices [MD 30]

• ENOU3330SAL0: Dental implant motor system
• ENOU3330IMP0: Dental implant motor system
• ENOU3330IDI0: Dental implant motor system
• ENOU3330CAM0: Dental implant motor system
• ENOU33300: Dental implant motor system
• ENOU2016IMP0: Dental implant motor system, SET
• ENOU2016IDI0: Dental implant motor system, SET
• ENOU20160: Dental implant motor system, SET
• ENOU2007SAL0: Dental implant motor system, SET
• ENOU20070: Dental implant motor system, SET
• ENOU2005IDI0: Dental implant motor system, SET
• ENOU2005CAM0: Dental implant motor system, SET
• ENOU20050: Dental implant motor system, SET
• ENOU2004SAL0: Dental implant motor system, SET
• ENOU2004IDI0: Dental implant motor system, SET
• ENOU2004CAM0: Dental implant motor system, SET
• ENOU20040: Dental implant motor system, SET