Swissmeda Dental Planning System

GUDID 07629999056220

Swissmeda AG

Dental treatment application software

• Primary Device ID: 07629999056220
• NIH Device Record Key: a74bfbb2-99c7-472d-b548-231f4da2eb0e
• Commercial Distribution Discontinuation: 2019-02-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Swissmeda Dental Planning System
• Version Model Number: 2.15
• Company DUNS: 485199660
• Company Name: Swissmeda 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: true
• Serial Number: false
• 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	07629999056220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112251

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-18
• Device Publish Date: 2018-12-23

On-Brand Devices [Swissmeda Dental Planning System]

• 07629999057654: 2.15.2
• 07629999056985: 2.15.1
• 07629999056220: 2.15
• 07629999052505: 2.14.2
• 07629999052109: 2.14.1
• 07629999048713: 2.14
• 07629999065512: 2.15.4
• 07629999061569: 2.15.3
• 07629999614178: 2.17.1
• 07629999062177: 2.20.0
• 07649997938014: SMOP Dental Planning System 2.21.0