Vera PDS

GUDID 90852187007173

Vera PDS Hard, Dental casting non-noble alloy

AALBA DENT INC.

Dental casting non-noble alloy

• Primary Device ID: 90852187007173
• NIH Device Record Key: 8bc0adc2-b574-4d48-8110-557bf8e8e6d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vera PDS
• Version Model Number: PDSH
• Company DUNS: 073944274
• Company Name: AALBA DENT 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: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: 7078643334
• Email: vince@aalbadent.com
• Phone: 7078643334
• Email: vince@aalbadent.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	90852187007173 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K915249

FDA Product Code

• EJH: Alloy, Metal, Base

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: 2016-10-11

On-Brand Devices [Vera PDS]

• 90852187007173: Vera PDS Hard, Dental casting non-noble alloy
• 90852187007142: Vera PDS Regular, Dental casting non-noble alloy