Everest

GUDID 08800118606895

U&C International Co.,Ltd

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800118606895
• NIH Device Record Key: 0b810a49-c80e-49ac-a3c0-c8eedc5a9f26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Everest
• Version Model Number: Z MO A2 16
• 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	08800118606895 [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: 2022-02-21
• Device Publish Date: 2022-02-12

On-Brand Devices [Everest]

• 08800118606956: Z MO A2 30
• 08800118606949: Z MO A2 28
• 08800118606932: Z MO A2 25
• 08800118606925: Z MO A2 22
• 08800118606918: Z MO A2 20
• 08800118606901: Z MO A2 18
• 08800118606895: Z MO A2 16
• 08800118606888: Z MO A2 14
• 08800118606871: Z MO A2 12
• 08800118606864: Z MO A2 10
• 08800118605850: W MO A2 30
• 08800118605843: W MO A2 28
• 08800118611394: W MO A3 30
• 08800118611387: W MO A3 28
• 08800118611370: W MO A3 25
• 08800118611363: W MO A3 22
• 08800118611356: W MO A3 20
• 08800118611349: W MO A3 18
• 08800118611332: W MO A3 16
• 08800118611325: W MO A3 14
• 08800118611318: W MO A3 12
• 08800118611301: W MO A3 10
• 08800118611295: W MO A1 30
• 08800118611288: W MO A1 28
• 08800118611271: W MO A1 25
• 08800118611264: W MO A1 22
• 08800118611257: W MO A1 20
• 08800118611240: W MO A1 18
• 08800118611233: W MO A1 16
• 08800118611226: W MO A1 14
• 08800118611219: W MO A1 12
• 08800118611202: W MO A1 10
• 08800118615224: W ML UV A4 30
• 08800118615217: W ML UV A4 28
• 08800118615200: W ML UV A4 25
• 08800118615194: W ML UV A4 22
• 08800118615187: W ML UV A4 20
• 08800118615170: W ML UV A4 18
• 08800118615163: W ML UV A4 16
• 08800118615156: W ML UV A4 14
• 08800118615149: W ML UV A4 12
• 08800118615132: W ML UV A4 10
• 08800118615125: W ML UV A3.5 30
• 08800118615118: W ML UV A3.5 28
• 08800118615101: W ML UV A3.5 25
• 08800118615095: W ML UV A3.5 22
• 08800118615088: W ML UV A3.5 20
• 08800118615071: W ML UV A3.5 18
• 08800118615064: W ML UV A3.5 16
• 08800118615057: W ML UV A3.5 14