CIMPAT WHITE 01E0120

GUDID 03760140703250

Temporary filling material

SEPTODONT SAS SPECIALITES SEPTODONT

Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement Endodontic temporary cement

• Primary Device ID: 03760140703250
• NIH Device Record Key: e75c718b-6803-44f4-a82f-95375cd1f177
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CIMPAT WHITE
• Version Model Number: 01E0120
• Catalog Number: 01E0120
• Company DUNS: 275273795
• Company Name: SEPTODONT SAS SPECIALITES SEPTODONT
• Device Count: 1
• DM Exempt: false
• 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: 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

Customer Support Contacts

• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com
• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com
• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com
• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com
• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com
• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com
• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com
• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com
• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com
• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com
• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com
• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com
• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com
• Phone: (303) 665-7535
• Email: usregulatoryaffairs@septodont.com

Device Dimensions

• Weight: 25 Gram
• Weight: 25 Gram
• Weight: 25 Gram
• Weight: 25 Gram
• Weight: 25 Gram
• Weight: 25 Gram
• Weight: 25 Gram
• Weight: 25 Gram
• Weight: 25 Gram
• Weight: 25 Gram
• Weight: 25 Gram
• Weight: 25 Gram
• Weight: 25 Gram
• Weight: 25 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760140703250 [Primary]

FDA Product Code

• EMA: Cement, Dental

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-09-22
• Device Publish Date: 2016-09-12

Devices Manufactured by SEPTODONT SAS SPECIALITES SEPTODONT

• 03760140703335 - BIODENTINE: 2023-06-13 Bioactive dentin substitute
• 03760140703366 - BIODENTINE - 5 PACK: 2023-06-13 Bioactive dentin substitute
• 03701398102709 - Ultra Safety Plus Twist kit 25G Long: 2022-10-10 100 needles 25G long (Red) and 1 handle (to be sterilized)
• 03701398101986 - Biodentine XP 200: 2022-02-15 Bioactive dentin substitute
• 03701398101993 - Biodentine XP 500: 2022-02-15 Bioactive dentin substitute
• 03701398102556 - BioRoot Flow- 2 g: 2022-02-09 Bioactive mineral Root Canal Sealer
• 03701398102563 - BioRoot Flow-0.5 g: 2022-02-09 Bioactive mineral Root Canal Sealer
• 33760140704371 - Endosolv: 2021-01-14 solvent for endodontic cements