Harmony PF 582013

GUDID D7075820130

Harmony PF 5 g

IVOCLAR VIVADENT, INC.

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• Primary Device ID: D7075820130
• NIH Device Record Key: 73ae5f83-c624-4af4-9ed6-6123364fc55f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harmony PF
• Version Model Number: 582013
• Catalog Number: 582013
• Company DUNS: 176935203
• Company Name: IVOCLAR VIVADENT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
HIBCC	D7075820130 [Primary]

FDA Product Code

• EJT: Alloy, gold-based noble metal

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: 2022-04-27
• Device Publish Date: 2018-10-29

On-Brand Devices [Harmony PF]

• D7075820160: Harmony PF 50 g
• D7075766000: Harmony PF 25 g
• D7075765910: Harmony PF 100 g
• D7075820150: Harmony PF 1oz/31 g
• D7075820130: Harmony PF 5 g