InstaRay 02HAM15302

GUDID 00858475006184

Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and oral structure.

DENTERPRISE INTERNATIONAL, INC.

Dental digital imaging sensor, intraoral

• Primary Device ID: 00858475006184
• NIH Device Record Key: 24e4dc84-ddbc-4757-ae2d-4686ae26a50f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InstaRay
• Version Model Number: Size 2
• Catalog Number: 02HAM15302
• Company DUNS: 024913248
• Company Name: DENTERPRISE INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 1-877-509-3180
• Email: info@denterpriseintl.com
• Phone: 1-877-509-3180
• Email: info@denterpriseintl.com
• Phone: 1-877-509-3180
• Email: info@denterpriseintl.com
• Phone: 1-877-509-3180
• Email: info@denterpriseintl.com
• Phone: 1-877-509-3180
• Email: info@denterpriseintl.com
• Phone: 1-877-509-3180
• Email: info@denterpriseintl.com
• Phone: 1-877-509-3180
• Email: info@denterpriseintl.com
• Phone: 1-877-509-3180
• Email: info@denterpriseintl.com
• Phone: 1-877-509-3180
• Email: info@denterpriseintl.com
• Phone: 1-877-509-3180
• Email: info@denterpriseintl.com
• Phone: 1-877-509-3180
• Email: info@denterpriseintl.com
• Phone: 1-877-509-3180
• Email: info@denterpriseintl.com
• Phone: 1-877-509-3180
• Email: info@denterpriseintl.com
• Phone: 1-877-509-3180
• Email: info@denterpriseintl.com
• Phone: 1-877-509-3180
• Email: info@denterpriseintl.com
• Phone: 1-877-509-3180
• Email: info@denterpriseintl.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858475006184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151926

FDA Product Code

• MUH: System, X-Ray, Extraoral Source, Digital

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: 2019-08-01
• Device Publish Date: 2019-07-24

On-Brand Devices [InstaRay]

• 00858475006184: Indications for Use: Radiographic examination and diagnosis of diseases of the teeth, jaw and o
• 00858475006177: Size 1