Nacera 4503300001

GUDID EDMC45033000010

Fully polymerized composite with optimized, high-density filler technology. Radiopaque, 8 shades. Flexural strength: 175 MPa (typical value). Modulus of elasticity: 9900 MPa (typical value).

DOCERAM medical ceramics GmbH

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• Primary Device ID: EDMC45033000010
• NIH Device Record Key: 988a9d17-75bb-4af0-8f08-7cc72cdf8f6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nacera
• Version Model Number: Hybrid A3 Disc
• Catalog Number: 4503300001
• Company DUNS: 537713567
• Company Name: DOCERAM medical ceramics 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: true
• 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: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us
• Phone: +49231925025952
• Email: RA@nacera.us

Device Dimensions

• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter
• Height: 20 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDMC45033000010 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130654

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-04-02
• Device Publish Date: 2017-11-17

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