EdgeIce

GUDID 00818365020065

EdgeIce Refrigerant pulp vitality spray is used in dentistry for the purpose of thermo testing of tooth vitality. For professional dental use only.

EDGE ENDO LLC

Cryogenic spray, dental

• Primary Device ID: 00818365020065
• NIH Device Record Key: 4a80dcdd-5aa5-4b1c-b1bb-51d77aa4a2fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeIce
• Version Model Number: EDGEICE
• Company DUNS: 078474365
• Company Name: EDGE ENDO 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: 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: true
• OTC Over-The-Counter: false

Device Dimensions

• Weight: 170 Gram
• Weight: 170 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818365020065 [Primary]

FDA Product Code

• EAT: Tester, Pulp

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-09-28

Devices Manufactured by EDGE ENDO LLC

• 00818365021031 - EdgeTemp™ Plus Hydraulic Temporary Restorative Material: 2020-09-07 EdgeTemp™ Plus is used for fabrication of temporary fillings for use until the permanent prosthetic is ready for installation.
• 10818365020932 - Edge™ EarLoop Procedure Masks”: 2020-05-06 Earloop Procedure Masks, ASTM Level 1, White, Box
• 10818365020949 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 1, Pink, Box
• 10818365020956 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 1, Blue, Box
• 10818365020963 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 2, White, Box
• 10818365020970 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 2, Pink, Box
• 10818365020987 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 2, Blue, Box
• 20818365020991 - Edge™ EarLoop Procedure Masks: 2020-05-06 Earloop Procedure Masks, ASTM Level 3, White, Box