Planmeca Compact 30021331, 30021332

GUDID 06430035420612

Planmeca Compact i3 is a dental operative unit with a dental patient chair. The unit is equipped with a digital control system and a user interface with a touch panel. The instrument console includes five instrument locations, with easy instrument change. The chair and the unit can be swiveled and it is suitable for both right and left-handed use.

Planmeca Oy

Dental delivery system

• Primary Device ID: 06430035420612
• NIH Device Record Key: be709fe4-babe-464d-bcbe-66ddea156ded
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Planmeca Compact
• Version Model Number: i3
• Catalog Number: 30021331, 30021332
• Company DUNS: 368788568
• Company Name: Planmeca Oy
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035420612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961420

FDA Product Code

• EIA: Unit, Operative Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-06
• Device Publish Date: 2019-10-29

On-Brand Devices [Planmeca Compact]

• 06430035420575: Planmeca Compact i5 is a dental operative unit including a dental patient chair. The unit is equ
• 06430035420438: Planmeca Compact i is a dental operative unit including a dental patient chair. The unit is equi
• 06430035420612: Planmeca Compact i3 is a dental operative unit with a dental patient chair. The unit is equipped