Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PMMA Block

K-Number: K201683 · 2020-11-03

ApplicantHuge Dental Material Co., Ltd.
Decision Date2020-11-03
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PMMA Block is a medical device manufactured by Huge Dental Material Co., Ltd.. It received FDA 510(k) clearance on 2020-11-03 under approval number K201683. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PMMA Block?

PMMA Block is a medical device that received FDA 510(k) clearance on 2020-11-03. It is manufactured by Huge Dental Material Co., Ltd.. The 510(k) number is K201683.

When was PMMA Block approved by the FDA?

PMMA Block received FDA 510(k) clearance on 2020-11-03, under approval number K201683.

What company makes PMMA Block?

PMMA Block is manufactured by Huge Dental Material Co., Ltd..

What is the FDA product code for PMMA Block?

The FDA product code for PMMA Block is EBG.

Related Devices (Code: EBG)

K153490DD medical polymersDental Direkt GmbH K152443Vericore Gradient Temporary DiscWhip Mix Corporation K153753TelioCAD MultiIvoclar Vivadent, Inc. K152215DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLORDentalplus GmbH K171729Fixtemp C&BDreve Dentamid GmbH K172281PuRE PMMA DiscQuest Dental USA Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑