Ceramill Splintec 760533

GUDID D709760533

Ceramill Splintec 98x20 N/US

Merz Dental GmbH

Removable dental occlusal splint, custom-made

• Primary Device ID: D709760533
• NIH Device Record Key: dc42ea31-d62e-494a-82f6-9d29f73df4d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramill Splintec
• Version Model Number: Ceramill Splintec 98x20 N/US
• Catalog Number: 760533
• Company DUNS: 324914910
• Company Name: Merz Dental GmbH
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de
• Phone: +494381403411
• Email: claudia.bobrowski@merz-dental.de

Device Dimensions

• Height: 20 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D709760533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K134015

FDA Product Code

• MQC: Mouthguard, Prescription

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-10-21
• Device Publish Date: 2016-09-24

On-Brand Devices [Ceramill Splintec]

• D709760533: Ceramill Splintec 98x20 N/US
• D709760532: Ceramill Splintec 98x14 N/US
• D709760319: Ceramill Splintec 71 L US 20mm
• D709760312: Ceramill Splintec 71 XS US 13mm