FDA.reportPublic FDA data

Everest / MegaPlus

Primary DI
08800118604792
Brand
Everest / MegaPlus
Company
U&C International Co.,Ltd
Model
W ML PT A4 25
Published
2022-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191902000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191902000Razor, Everest, U&C LiquidU&C International Co., Ltd.2019-10-11EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800118604792PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800118604792088001186047928800118604792

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
694821663
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800118646365ZublerW 1100 XA1 222026-01-05
08800118646372ZublerW 1100 XA1 202026-01-05
08800118646389Razor / MegaPlusW 1100 BL3 352026-01-05
08800118646396Razor / MegaPlusW 1100 BL2 352026-01-05
08800118646402Razor / MegaPlusW 1100 BL1 352026-01-05
08800118646419ZublerW 1100 ABL3 352026-01-05
08800118646426ZublerW 1100 ABL3 222026-01-05
08800118646433ZublerW 1100 ABL3 202026-01-05
08800118646440ZublerW 1100 AB1 222026-01-05
08800118646457ZublerW 1100 AB1 202026-01-05
08800118646464Razor / MegaPlusW 1100 A2 352026-01-05
08800118623984Razor / MegaPlusW 1300 A3.5 102023-03-03
08800118623991Razor / MegaPlusW 1300 A3.5 122023-03-03
08800118624004Razor / MegaPlusW 1300 A3.5 142023-03-03
08800118624011Razor / MegaPlusW 1300 A3.5 162023-03-03
08800118624028Razor / MegaPlusW 1300 A3.5 182023-03-03
08800118624035Razor / MegaPlusW 1300 A3.5 202023-03-03
08800118624042Razor / MegaPlusW 1300 A3.5 222023-03-03
08800118624059Razor / MegaPlusW 1300 A3.5 252023-03-03
08800118624066Razor / MegaPlusW 1300 A3.5 282023-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942508892586ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06942508892593ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06976691250007ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06976691250014ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501003ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501010ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501027ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501034ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501041ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501058ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501065ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
06978951501072ZIRCONIA BLOCKHangzhou IVISTA Medical Devices Co., Ltd.EIH2026-07-10
07615208543582IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543599IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543674IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543681IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543698IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543704IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543711IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543728IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543735IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543858IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543865IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543872IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543889IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543896IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543902IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208543919IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544039IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07
07615208544046IPS e.max ZirconiaIVOCLAR VIVADENT AKTIENGESELLSCHAFTEIH2026-07-07