Crowntec 8051

GUDID D93180511

saremco print CROWNTEC is a light-curing, flowable polymer based on methacrylic acid ester for production of 3D-printed permanent crowns, inlays, onlays, veneers, tem- porary crowns & bridges, and artificial teeth (i.e., complete or partial dentures).

Saremco Dental AG

Dental appliance fabrication material, resin

• Primary Device ID: D93180511
• NIH Device Record Key: 3a0655b9-d4fc-4b65-b323-ce594892a56d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Crowntec
• Version Model Number: A3
• Catalog Number: 8051
• Company DUNS: 480619001
• Company Name: Saremco Dental AG
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D93180511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213343

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-23
• Device Publish Date: 2022-03-15

On-Brand Devices [Crowntec]

• D93180661: saremco print CROWNTEC is a light-curing, flowable polymer based on methacrylic acid ester for p
• D93180651: saremco print CROWNTEC is a light-curing, flowable polymer based on methacrylic acid ester for p
• D93180631: saremco print CROWNTEC is a light-curing, flowable polymer based on methacrylic acid ester for p
• D93180521: saremco print CROWNTEC is a light-curing, flowable polymer based on methacrylic acid ester for p
• D93180511: saremco print CROWNTEC is a light-curing, flowable polymer based on methacrylic acid ester for p