The Gripper® SPD1418

GUDID D813SPD14180

GRIPPER TRAY FULL ARCH MED

DEN-MAT HOLDINGS, LLC

Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use Dental impression tray, single-use

• Primary Device ID: D813SPD14180
• NIH Device Record Key: aa5f71a0-e32b-4ad9-bd18-27b0fef33c95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Gripper®
• Version Model Number: SPD1418
• Catalog Number: SPD1418
• Company DUNS: 809857704
• Company Name: DEN-MAT HOLDINGS, LLC
• 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: true
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com
• Phone: 18004336628
• Email: info@denmat.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D813SPD14180 [Primary]

FDA Product Code

• EHY: Tray, Impression, Preformed

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: 2022-10-03
• Device Publish Date: 2022-09-23

On-Brand Devices [The Gripper®]

• D813SPD15410: GRIPPER TRAY SIDELES POSTERIOR
• D813SPD14170: GRIPPER TRAY FULL ARCH LG
• D813SPD14160: GRIPPER TRAY 3/4 ARCH
• D813SPD14150: GRIPPER TRAY POSTERIOR
• D813SPD14140: GRIPPER TRAY ANTERIOR
• D813SPD14180: GRIPPER TRAY FULL ARCH MED