CORiTEC PMMA transpa Disc 52500598220

GUDID D70952500598220

CORiTEC PMMA transpa Disc thickness 20mm, diameter 98,5mm, clear, with notch

Merz Dental GmbH

Removable dental occlusal splint, custom-made

• Primary Device ID: D70952500598220
• NIH Device Record Key: 878dcbbd-d59d-4f99-9d6c-eed88a82b00e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORiTEC PMMA transpa Disc
• Version Model Number: CORiTEC PMMA transpa Disc thickness 20mm, diameter
• Catalog Number: 52500598220
• 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: 98.5 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98.5 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 98.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D70952500598220 [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: 2017-09-30

Devices Manufactured by Merz Dental GmbH

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• D7091010330 - integral: 2025-09-09 Living mould chart integral A3 containing: 10 upper and 11 lower anterior sets, 4 upper and 4 lower posteriors sets
• D7091010333 - artegral life: 2025-09-09 Living mould chart artegral life in shade A3 containing: 20 upper and 13 lower anterior sets, 5 upper and 5 lower posterior sets
• D7091010335 - artVeneer life: 2025-09-09 Living mould chart artVeneer life in shade A3 containing: 20 upper and 13 lower anterior sets, 5 upper and 5 lower posterior set
• D7091010337 - Polystar Selection EDITION / Polystar Selection EDITION HD: 2025-09-09 Living mould chart Polystar Selection EDITION / Polystar Selection EDITION HD in shade A3 containing: 21 upper and 9 lower anter
• D7091010341 - Polystar HK: 2025-09-09 Living mould chart Polystar HK in shade A3 containing: 30 upper and 15 lower anterior sets, 9 upper and 9 lower posterior sets
• D7091010343 - DeltaForm: 2025-09-09 Living mould chart DeltaForm in shade A3 containing: 5 upper and 5 lower posterior sets
• D7091010344 - DeltaForm HD: 2025-09-09 Living mould chart DeltaForm HD in shade A3 containing: 5 upper and 5 lower HD posterior sets