Nexcomp Unidose B1

GUDID 08806387894643

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 Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device ID08806387894643
NIH Device Record Key5dd2cf6f-e234-482a-b37b-e3ef38cea1ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameNexcomp Unidose B1
Version Model Number9464
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806387894643 [Primary]

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 Number3
Public Version Date2021-10-18
Device Publish Date2018-11-30

On-Brand Devices [Nexcomp Unidose B1]

08806387894643Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque a
08806387892656Nexcomp is a highly filled (75 wt.%), light-cured hybrid composite. The material is radiopaque a

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.