Health-Tec Bite Registration Material 150-102B

GUDID D773150102B1

Health-Tec Bite Registration Material, Fast Set, Unflavored, Bulk Pack

Dental Health Products Inc

Silicone dental impression material

• Primary Device ID: D773150102B1
• NIH Device Record Key: 115eaa9d-e42e-4a32-82c2-463331ff1c90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health-Tec Bite Registration Material
• Version Model Number: 150-102B
• Catalog Number: 150-102B
• Company DUNS: 623191194
• Company Name: Dental Health Products Inc
• Device Count: 25
• 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

Customer Support Contacts

• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Avoid direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place. Avoid direct sunlight.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D773150102B0 [Unit of Use]
HIBCC	D773150102B1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041028

FDA Product Code

• ELW: Material, Impression

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: 2017-01-24

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• D773150103B1: Health-Tec Bite Registration Material, Super Fast Set, Unflavored, Bulk Pack
• D7731501031: Health-Tec Bite Registration Material, Super Fast Set, Unflavored
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• D7731501021: Health-Tec Bite Registration Material, Fast Set, Unflavored
• D7731501011: Health-Tec Bite Registration Material, Regular Set, Unflavored