PolyCast

GUDID D8701005516

PolyCast Clear Disc, 98.5 X 16mm

Harvest Dental Products, LLC

Temporary dental crown/bridge resin

• Primary Device ID: D8701005516
• NIH Device Record Key: 1692d98c-8f51-48b1-a3f2-b11c4c72ab72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PolyCast
• Version Model Number: 10055-16
• Company DUNS: 794668751
• Company Name: Harvest Dental Products, LLC
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com
• Phone: 7146747400
• Email: hello@harvestdental.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D8701005516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102341

FDA Product Code

• EBG: Crown And Bridge, Temporary, 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: 2023-02-28
• Device Publish Date: 2023-02-20

On-Brand Devices [PolyCast]

• D870700544031: PolyCast Red 40mm Inlab Block
• D870700524031: PolyCast Clear 40mm Inlab Block
• D87010055251: PolyCast Clear Disc, 98 X 25mm
• D87010055201: PolyCast Clear Disc, 98 X 20mm
• D8701005516: PolyCast Clear Disc, 98.5 X 16mm