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 Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin Dental appliance fabrication material, resin 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