BEGO VarseoSmile Crown Plus A1 250g

GUDID D040711911

BEGO VarseoSmile Crown Plus A1 250g

WHIP-MIX CORPORATION

Custom-made dental crown, polymer

• Primary Device ID: D040711911
• NIH Device Record Key: 520aa91a-4711-45a5-bac8-d86fb712dc53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BEGO VarseoSmile Crown Plus A1 250g
• Version Model Number: 71191
• Company DUNS: 006385173
• Company Name: WHIP-MIX CORPORATION
• 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: true
• 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
HIBCC	D040711911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201668

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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: 2021-09-06
• Device Publish Date: 2021-08-27

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