DENTCA Tray

GUDID 00856551007193

Starter Kit

DENTCA, INC.

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

• Primary Device ID: 00856551007193
• NIH Device Record Key: 04570feb-3c89-4551-b057-555292ef0dc6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENTCA Tray
• Version Model Number: DENTCA Starter Kit
• Company DUNS: 022455143
• Company Name: DENTCA, 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: true
• Lot Batch: false
• 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: false

Customer Support Contacts

• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com
• Phone: +1(424)558-8726
• Email: info@dentca.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856551007193 [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: 2021-11-11
• Device Publish Date: 2021-11-03

On-Brand Devices [DENTCA Tray]

• 00856551007193: Starter Kit
• 00856551007186: Single Arch Attachment (Upper & Lower) - Large & Extra Large
• 00856551007179: Single Arch Attachment (Upper & Lower) - Small & Medium
• 00856551007162: Tray - Small
• 00856551007155: Tray - Medium
• 00856551007148: Tray - Large
• 00856551007131: Tray - Extra Large
• 00856551007124: EZ Tracer
• 00856551007117: Jaw Gauge
• 00856551007100: Lip Ruler