Gingivamoll Starter-Kit

GUDID EDET30521

DETAX GmbH & Co. KG

Cosmetic silicone-liquid tissue reconstructive material

• Primary Device ID: EDET30521
• NIH Device Record Key: 49e87895-b30e-4a0d-a1d4-57356f6d34d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gingivamoll Starter-Kit
• Version Model Number: 03052
• Company DUNS: 317099257
• Company Name: DETAX GmbH & Co. KG
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDET30521 [Primary]

FDA Product Code

• NOK: Material, External Aesthetic Restoration, No Adhesive

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: 2022-10-24
• Device Publish Date: 2022-10-14

Devices Manufactured by DETAX GmbH & Co. KG

• EDET021651 - detax Impression lacquer 1000 ml: 2022-11-03
• EDET025891 - detax Impression lacquer 30 ml: 2022-11-03
• EDET041641 - medicalprint shell blue opaque 1000g: 2022-11-03
• EDET041651 - medicalprint shell red opaque 1000g: 2022-11-03
• EDET042301 - detax softwear 2.0 clear 40 shore 8x 50 ml: 2022-11-03
• EDET042381 - detax softwear 2.0 blue 60 shore 2 x 50 ml: 2022-11-03
• EDET042461 - luxaprint flex UV 500 g: 2022-11-03
• EDET027231 - aquaplus putty blue 2 x 250 ml: 2022-11-02