temp:ex 66000000

GUDID J009660000000

Cleanser for dissolving temporary cement from dental restorations, liquid

Renfert GmbH

Denture cleanser Denture cleanser Denture cleanser Denture cleanser Denture cleanser Denture cleanser Denture cleanser Denture cleanser Denture cleanser Denture cleanser Denture cleanser Denture cleanser Denture cleanser Denture cleanser Denture cleanser Denture cleanser Denture cleanser

• Primary Device ID: J009660000000
• NIH Device Record Key: b8c0060d-1f5b-4cb9-87c2-be74c3c4c21e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: temp:ex
• Version Model Number: 66000000
• Catalog Number: 66000000
• Company DUNS: 328502976
• Company Name: Renfert GmbH
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J009660000000 [Primary]

FDA Product Code

• NUX: Cleanser, Denture, Prescription

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: 2023-07-18
• Device Publish Date: 2023-07-10

Devices Manufactured by Renfert GmbH

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• J00927610010000 - DUOMIX II: 2023-07-18 Dental impression material mixer, Brand Dentsply-Sirona
• J00927700010000 - PROMIX one: 2023-07-18 Dental mixer of Surefill one and Calibra Bio capsules, Brand Dentsply Sirona
• J009600010000 - SYMPRESS: 2023-07-18 Dental impression material mixer, type 1
• J009610010000 - SYMPRESS II: 2023-07-18 Dental impression material mixer, type 2
• J009660000000 - temp:ex: 2023-07-18Cleanser for dissolving temporary cement from dental restorations, liquid
• J009660000000 - temp:ex: 2023-07-18 Cleanser for dissolving temporary cement from dental restorations, liquid
• J009670000000 - help:ex plaque p: 2023-07-18 Cleanser for the removal of tartar and plaque on dental prostheses, Portioned with neutraliser, powder
• J009670000010 - help:ex plaque p, sample: 2023-07-18 Cleanser for the removal of tartar and plaque on dental prostheses, Portioned with neutraliser, powder, sample