Everest / MegaPlus

GUDID 08800118601449

U&C International Co.,Ltd

Dental appliance fabrication material, ceramic

• Primary Device ID: 08800118601449
• NIH Device Record Key: 28710f6c-7959-4762-a161-8d48f01e9d7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Everest / MegaPlus
• Version Model Number: 5151 HT A2 98-10
• 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	08800118601449 [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: 2022-01-18
• Device Publish Date: 2022-01-10

On-Brand Devices [Everest / MegaPlus]

• 08800118601005: W 800 A0 18
• 08800118602002: D 1300 A3 10
• 08800118601999: D 1300 A2 25
• 08800118601982: D 1300 A2 22
• 08800118601975: D 1300 A2 20
• 08800118601968: D 1300 A2 18
• 08800118601951: D 1300 A2 16
• 08800118601944: D 1300 A2 14
• 08800118601937: D 1300 A2 12
• 08800118601920: D 1300 A2 10
• 08800118601913: D 1300 A1 25
• 08800118601906: D 1300 A1 22
• 08800118601890: D 1300 A1 20
• 08800118601883: D 1300 A1 18
• 08800118601876: D 1300 A1 16
• 08800118601869: D 1300 A1 14
• 08800118601852: D 1300 A1 12
• 08800118601845: D 1300 A1 10
• 08800118601838: D 1300 A0 25
• 08800118601821: D 1300 A0 22
• 08800118601814: D 1300 A0 20
• 08800118601807: D 1300 A0 18
• 08800118601791: D 1300 A0 16
• 08800118601784: D 1300 A0 14
• 08800118601777: D 1300 A0 12
• 08800118601760: D 1300 A0 10
• 08800118601753: 5188 LT WH 98-25
• 08800118601746: 5187 LT WH 98-22
• 08800118601739: 5186 LT WH 98-20
• 08800118601722: 5185 LT WH 98-18
• 08800118601715: 5184 LT WH 98-16
• 08800118601708: 5183 LT WH 98-14
• 08800118601692: 5182 LT WH 98-12
• 08800118601685: 5181 LT WH 98-10
• 08800118601678: 5178 LT A2 98-25
• 08800118601661: 5177 LT A2 98-22
• 08800118601654: 5176 LT A2 98-20
• 08800118601647: 5175 LT A2 98-18
• 08800118601630: 5174 LT A2 98-16
• 08800118601623: 5173 LT A2 98-14
• 08800118601616: 5172 LT A2 98-12
• 08800118601609: 5171 LT A2 98-10
• 08800118601593: 5168 HT WH 98-25
• 08800118601586: 5167 HT WH 98-22
• 08800118601579: 5166 HT WH 98-20
• 08800118601562: 5165 HT WH 98-18
• 08800118601555: 5164 HT WH 98-16
• 08800118601548: 5163 HT WH 98-14
• 08800118601531: 5162 HT WH 98-12
• 08800118601524: 5161 HT WH 98-10