Hyramic CAD/CAM Restorative

GUDID 06941382250697

Liaoning Upcera Co.,Ltd.

Dental appliance fabrication material, ceramic

• Primary Device ID: 06941382250697
• NIH Device Record Key: 46a8ea42-60d6-44a1-98bd-11c16f4a3a5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hyramic CAD/CAM Restorative
• Version Model Number: HT-S-C4-R(18-14-12)
• Company DUNS: 548214192
• Company Name: Liaoning Upcera Co.,Ltd.
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06941382250697 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162323

FDA Product Code

• EBF: Material, Tooth Shade, Resin
• EIH: Powder, Porcelain

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-19
• Device Publish Date: 2019-03-16

On-Brand Devices [Hyramic CAD/CAM Restorative]

• 06941382252486: LT-M-D4-D(98-20)
• 06941382252479: LT-M-D3-D(98-20)
• 06941382252462: LT-M-D2-D(98-20)
• 06941382252455: LT-M-C4-D(98-20)
• 06941382252448: LT-M-C3-D(98-20)
• 06941382252431: LT-M-C2-D(98-20)
• 06941382252424: LT-M-C1-D(98-20)
• 06941382252417: LT-M-B4-D(98-20)
• 06941382252400: LT-M-B3-D(98-20)
• 06941382252394: LT-M-B2-D(98-20)
• 06941382252387: LT-M-B1-D(98-20)
• 06941382252370: LT-M-A4-D(98-20)
• 06941382252363: LT-M-A3.5-D(98-20)
• 06941382252356: LT-M-A3-D(98-20)
• 06941382252349: LT-M-A2-D(98-20)
• 06941382252332: LT-M-A1-D(98-20)
• 06941382252325: LT-S-D4-D(98-20)
• 06941382252318: LT-S-D3-D(98-20)
• 06941382252301: LT-S-D2-D(98-20)
• 06941382252295: LT-S-C4-D(98-20)
• 06941382252288: LT-S-C3-D(98-20)
• 06941382252271: LT-S-C2-D(98-20)
• 06941382252264: LT-S-C1-D(98-20)
• 06941382252257: LT-S-B4-D(98-20)
• 06941382252240: LT-S-B3-D(98-20)
• 06941382252233: LT-S-B2-D(98-20)
• 06941382252226: LT-S-B1-D(98-20)
• 06941382252219: LT-S-A4-D(98-20)
• 06941382252202: LT-S-A3.5-D(98-20)
• 06941382252196: LT-S-A3-D(98-20)
• 06941382252189: LT-S-A2-D(98-20)
• 06941382252172: LT-S-A1-D(98-20)
• 06941382252165: HT-M-D4-D(98-20)
• 06941382252158: HT-M-D3-D(98-20)
• 06941382252141: HT-M-D2-D(98-20)
• 06941382252134: HT-M-C4-D(98-20)
• 06941382252127: HT-M-C3-D(98-20)
• 06941382252110: HT-M-C2-D(98-20)
• 06941382252103: HT-M-C1-D(98-20)
• 06941382252097: HT-M-B4-D(98-20)
• 06941382252080: HT-M-B3-D(98-20)
• 06941382252073: HT-M-B2-D(98-20)
• 06941382252066: HT-M-B1-D(98-20)
• 06941382252059: HT-M-A4-D(98-20)
• 06941382252042: HT-M-A3.5-D(98-20)
• 06941382252035: HT-M-A3-D(98-20)
• 06941382252028: HT-M-A2-D(98-20)
• 06941382252011: HT-M-A1-D(98-20)
• 06941382252004: HT-S-D4-D(98-20)
• 06941382251991: HT-S-D3-D(98-20)