Nexcomp B1

GUDID 08806387892311

Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque and indicated for all types of cavity preparations. The hybrid blend has an ultra fine filler and 40 nm silica particles. Nexcomp will be marketed in incisal, body translucent, and body opaque shades which correspond with the Vita shade guide.

Meta Biomed Co., Ltd.

Dental composite resin
Primary Device ID08806387892311
NIH Device Record Keyb07c4c7a-d3c2-44c9-a468-d626519b3a02
Commercial Distribution StatusIn Commercial Distribution
Brand NameNexcomp B1
Version Model Number9231
Company DUNS688322841
Company NameMeta Biomed Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806387892311 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-10-18
Device Publish Date2016-09-19

On-Brand Devices [Nexcomp B1]

08806387894438Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque a
08806387892311Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque a

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