MK-dent HE21SL

GUDID E490HE21SL1

Turbine

MK-Dent GmbH

Dental power tool handpiece motorless component

• Primary Device ID: E490HE21SL1
• NIH Device Record Key: 2d2ca0fe-7019-4d5d-b092-9ccd035c5041
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MK-dent
• Version Model Number: ECO LINE
• Catalog Number: HE21SL
• 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: true
• 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	04050546001524 [Previous]
HIBCC	E490HE21SL1 [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

[E490HE21SL1]

Moist Heat or Steam Sterilization

[E490HE21SL1]

Moist Heat or Steam Sterilization

[E490HE21SL1]

Moist Heat or Steam Sterilization

[E490HE21SL1]

Moist Heat or Steam Sterilization

[E490HE21SL1]

Moist Heat or Steam Sterilization

[E490HE21SL1]

Moist Heat or Steam Sterilization

[E490HE21SL1]

Moist Heat or Steam Sterilization

[E490HE21SL1]

Moist Heat or Steam Sterilization

[E490HE21SL1]

Moist Heat or Steam Sterilization

[E490HE21SL1]

Moist Heat or Steam Sterilization

[E490HE21SL1]

Moist Heat or Steam Sterilization

[E490HE21SL1]

Moist Heat or Steam Sterilization

[E490HE21SL1]

Moist Heat or Steam Sterilization

[E490HE21SL1]

Moist Heat or Steam Sterilization

[E490HE21SL1]

Moist Heat or Steam Sterilization

[E490HE21SL1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-10-22
• Device Publish Date: 2024-10-14

On-Brand Devices [MK-dent]

• LCH211: Contra Angle Head
• E490QC6116KW1: Coupling
• E490QC6116K1: Coupling
• E490QC6016SW1: Coupling
• E490QC6016NT1: Coupling
• E490QC6016KW1: Coupling
• E490QC6016K1: Coupling
• E490QC5116KW1: Coupling
• E490QC5116K1: Coupling
• E490QC5016W1: Coupling
• E490QC5016SW1: Coupling
• E490QC5016NT1: Coupling
• E490QC5016KW1: Coupling
• E490QC5016K1: Coupling
• E490QC5015K1: Coupling
• E490QC4014W1: Coupling
• E490QC4014NT1: Coupling
• E490QC4014K1: Coupling
• E490QC4012K1: Coupling
• E490LU10311: Lubricant for maintenance
• E490LU10221: Lubricant for maintenance
• E490LU10111: Lubricant for maintenance
• E490LPH211: Contra Angle Head
• E490LPH161: Contra Angle Head
• E490LPH111: Contra Angle Head
• E490LP74L1: Contra Angle Handpiece
• E490LP54L1: Contra Angle Handpiece
• E490LP27L1: Contra Angle Handpiece
• E490LP15L1: Contra Angle Handpiece
• E490LP11L1: Contra Angle Handpiece
• E490LP01L1: Straight Handpiece
• E490LE74L1: Contra Angle Handpiece
• E490LE741: Contra Angle Handpiece
• E490LE54P1: Contra Angle Prophy Handpiece
• E490LE54LP1: Contra Angle Prophy Handpiece
• E490LE54L1: Contra Angle Handpiece
• E490LE541: Contra Angle Handpiece
• E490LE27L1: Contra Angle Handpiece
• E490LE271: Contra Angle Handpiece
• E490LE21P1: Contra Angle Prophy Handpiece
• E490LE21L1: Contra Angle Handpiece
• E490LE211: Contra Angle Handpiece
• E490LE16L1: Contra Angle Handpiece
• E490LE161: Contra Angle Handpiece
• E490LE15L1: Contra Angle Handpiece
• E490LE151: Contra Angle Handpiece
• E490LE148P1: Contra Angle Prophy Handpiece
• E490LE148LP1: Contra Angle Prophy Handpiece
• E490LE148L1: Contra Angle Handpiece
• E490LE1481: Contra Angle Handpiece