RACEGEL 01C0500

GUDID 03760140703359

Thermo-gelifiable gel for gingival preparation

SEPTODONT SAS SPECIALITES SEPTODONT

Gingival retraction kit

• Primary Device ID: 03760140703359
• NIH Device Record Key: 87abdf9f-668b-4502-a9a4-d1d7a88ab082
• Commercial Distribution Discontinuation: 2025-04-02
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: RACEGEL
• Version Model Number: 01C0500
• Catalog Number: 01C0500
• 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: true
• 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

Device Dimensions

• Weight: 1.4 Gram
• Weight: 1.4 Gram
• Weight: 1.4 Gram
• Weight: 1.4 Gram
• Weight: 1.4 Gram
• Weight: 1.4 Gram
• Weight: 1.4 Gram
• Weight: 1.4 Gram
• Weight: 1.4 Gram

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760140703359 [Primary]

FDA Product Code

• MVL: Cord, Retraction

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: 2025-04-03
• Device Publish Date: 2016-09-12

Devices Manufactured by SEPTODONT SAS SPECIALITES SEPTODONT

• 03760140703359 - RACEGEL: 2025-04-03Thermo-gelifiable gel for gingival preparation
• 03760140703359 - RACEGEL: 2025-04-03 Thermo-gelifiable gel for gingival preparation
• 07897990328435 - SeptoWedges Refill: 100 Asst. wooden wedges: 2025-03-12 wooden wedges
• 07897990328459 - SeptoMatrix Sectional Refill: 50 assorted matrices: 2025-03-12 Preformed sectional matrices systems for Class II restorations.
• 07897990328466 - SeptoMatrix Sectional Refill: 50 large matrices: 2025-03-12 Preformed sectional matrices systems for Class II restorations.
• 07897990328473 - SeptoMatrix Sectional Refill: 50 medium matrices: 2025-03-12 Preformed sectional matrices systems for Class II restorations.
• 07897990328480 - SeptoMatrix Sectional Refill: 50 small matrices: 2025-03-12 Preformed sectional matrices systems for Class II restorations.
• 07897990328718 - SeptoPlus Mandrel Refill: 1 mandrel snap: 2025-03-12 Mandrel for contra angle
• 07897990328725 - SeptoDiscs Kit: 120 assorted abrasive discs+ mandrel pop-on: 2025-03-12 Finishing and polishing discs for composites