Triton 90-2015

GUDID 00850309007091

Triton Dental System

ASI MEDICAL, INC.

Dental delivery system instrument unit, electric

• Primary Device ID: 00850309007091
• NIH Device Record Key: 5c4d5fb0-09b4-453b-b951-67e50df24d6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Triton
• Version Model Number: 90-2015
• Catalog Number: 90-2015
• Company DUNS: 808695159
• Company Name: ASI MEDICAL, INC.
• 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

Operating and Storage Conditions

• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850309007091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110481

FDA Product Code

• EIA: Unit, Operative Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-31

On-Brand Devices [Triton]

• 00850309007121: Triton Dental System
• 00850309007114: Triton Dental System
• 00850309007107: Triton Dental System
• 00850309007091: Triton Dental System
• 00850309007084: Triton Dental System
• 00850309007077: Triton Dental System
• 00850309007060: Triton Assistant’s System