Primo Dental Products

GUDID 00850080491034

Primo Dental

ECOTEC MANUFACTURING, INC.

Cryogenic spray, dental

• Primary Device ID: 00850080491034
• NIH Device Record Key: 203c653d-e65d-4316-ba15-61a6c8bdb7ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Primo Dental Products
• Version Model Number: RE152SP
• Company DUNS: 121411859
• Company Name: ECOTEC MANUFACTURING, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: 888-448-4274
• Email: dominickc@tristatedental.com
• Phone: 888-448-4274
• Email: dominickc@tristatedental.com
• Phone: 888-448-4274
• Email: dominickc@tristatedental.com
• Phone: 888-448-4274
• Email: dominickc@tristatedental.com
• Phone: 888-448-4274
• Email: dominickc@tristatedental.com
• Phone: 888-448-4274
• Email: dominickc@tristatedental.com
• Phone: 888-448-4274
• Email: dominickc@tristatedental.com
• Phone: 888-448-4274
• Email: dominickc@tristatedental.com
• Phone: 888-448-4274
• Email: dominickc@tristatedental.com
• Phone: 888-448-4274
• Email: dominickc@tristatedental.com
• Phone: 888-448-4274
• Email: dominickc@tristatedental.com
• Phone: 888-448-4274
• Email: dominickc@tristatedental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850080491034 [Primary]
GS1	10850080491031 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Product Code

• EAT: Tester, Pulp

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: 2025-12-04
• Device Publish Date: 2025-11-26

Devices Manufactured by ECOTEC MANUFACTURING, INC.

• 00850080491034 - Primo Dental Products: 2025-12-04Primo Dental
• 00850080491034 - Primo Dental Products: 2025-12-04 Primo Dental
• 00860177000681 - DYNAMIC FREEZE: 2025-08-06 Medical Freeze Spray
• 00860177000698 - Allure Ortho: 2025-08-06 ORTHODONTICFREEZE SPRAY
• 00817744022720 - Primo Freeze: 2024-10-10 Endo Freeze Spray
• 00752080000035 - SkyChoice Polar-Freeze: 2024-10-03 Endo Freeze Spray
• 00752080000028 - Hexa Freeze: 2024-10-02 Endo Freeze Spray
• 00752080000011 - RMH3 Dental: 2024-08-27 Endo Freeze Spray
• 00810132807435 - HOUSE BRAND DENTISTRY: 2024-03-26 PULP FREEZE SPRAY