LavaStone

GUDID 08800118625810

U&C International Co.,Ltd

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800118625810
• NIH Device Record Key: 2d87fb71-98d2-4f2f-a24f-67ea437d12bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LavaStone
• Version Model Number: W LS A2 25
• Company DUNS: 694821663
• Company Name: U&C International 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800118625810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191902

FDA Product Code

• EIH: Powder, Porcelain

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: 2023-03-13
• Device Publish Date: 2023-03-03

On-Brand Devices [LavaStone]

• 08800118626039: W LS A3.5 30
• 08800118626022: W LS A3.5 28
• 08800118626015: W LS A3.5 25
• 08800118626008: W LS A3.5 22
• 08800118625995: W LS A3.5 20
• 08800118625988: W LS A3.5 18
• 08800118625971: W LS A3.5 16
• 08800118625964: W LS A3.5 14
• 08800118625957: W LS A3.5 12
• 08800118625940: W LS A3.5 10
• 08800118625933: W LS A3 30
• 08800118625926: W LS A3 28
• 08800118625919: W LS A3 25
• 08800118625902: W LS A3 22
• 08800118625896: W LS A3 20
• 08800118625889: W LS A3 18
• 08800118625872: W LS A3 16
• 08800118625865: W LS A3 14
• 08800118625858: W LS A3 12
• 08800118625841: W LS A3 10
• 08800118625834: W LS A2 30
• 08800118625827: W LS A2 28
• 08800118625810: W LS A2 25
• 08800118625803: W LS A2 22
• 08800118625797: W LS A2 20
• 08800118625780: W LS A2 18
• 08800118625773: W LS A2 16
• 08800118625766: W LS A2 14
• 08800118625759: W LS A2 12
• 08800118625742: W LS A2 10
• 08800118625735: W LS A1 30
• 08800118625728: W LS A1 28
• 08800118625711: W LS A1 25
• 08800118625704: W LS A1 22
• 08800118625698: W LS A1 20
• 08800118625681: W LS A1 18
• 08800118625674: W LS A1 16
• 08800118625667: W LS A1 14
• 08800118625650: W LS A1 12
• 08800118625643: W LS A1 10