Chairside Zirconia

GUDID 08800099965349

Vatech mcis Co., Ltd

Dental appliance fabrication material, ceramic
Primary Device ID08800099965349
NIH Device Record Key00ae5f8c-af83-434f-95c3-2bbe9d22a31e
Commercial Distribution StatusIn Commercial Distribution
Brand NameChairside Zirconia
Version Model NumberFH C14 D3
Company DUNS688284886
Company NameVatech mcis Co., Ltd
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800099964700 [Primary]
GS108800099965349 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-08
Device Publish Date2023-11-30

On-Brand Devices [Chairside Zirconia]

08800099965837FH C16 D4M
08800099965820FH C16 D3M
08800099965813FH C16 D2M
08800099965806FH C16 C4M
08800099965790FH C16 C3M
08800099965783FH C16 C2M
08800099965776FH C16 C1M
08800099965769FH C16 B4M
08800099965752FH C16 B3M
08800099965745FH C16 B2M
08800099965738FH C16 B1M
08800099965721FH C16 A4M
08800099965714FH C16 A3.5M
08800099965707FH C16 A3M
08800099965691FH C16 A2M
08800099965684FH C16 A1M
08800099965677FH C16 D4
08800099965660FH C16 D3
08800099965653FH C16 D2
08800099965646FH C16 C4
08800099965639FH C16 C3
08800099965622FH C16 C2
08800099965615FH C16 C1
08800099965608FH C16 B4
08800099965592FH C16 B3
08800099965585FH C16 B2
08800099965578FH C16 B1
08800099965561FH C16 A4
08800099965554FH C16 A3.5
08800099965547FH C16 A3
08800099965530FH C16 A2
08800099965523FH C16 A1
08800099965516FH C14 D4M
08800099965509FH C14 D3M
08800099965493FH C14 D2M
08800099965486FH C14 C4M
08800099965479FH C14 C3M
08800099965462FH C14 C2M
08800099965455FH C14 C1M
08800099965448FH C14 B4M
08800099965431FH C14 B3M
08800099965424FH C14 B2M
08800099965417FH C14 B1M
08800099965400FH C14 A4M
08800099965394FH C14 A3.5M
08800099965387FH C14 A3M
08800099965370FH C14 A2M
08800099965363FH C14 A1M
08800099965356FH C14 D4
08800099965349FH C14 D3

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