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)

CeraSeal

K-Number: K190503 · 2019-06-07

ApplicantMeta Biomed Co., Ltd.
Decision Date2019-06-07
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CeraSeal is a medical device manufactured by Meta Biomed Co., Ltd.. It received FDA 510(k) clearance on 2019-06-07 under approval number K190503. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CeraSeal?

CeraSeal is a medical device that received FDA 510(k) clearance on 2019-06-07. It is manufactured by Meta Biomed Co., Ltd.. The 510(k) number is K190503.

When was CeraSeal approved by the FDA?

CeraSeal received FDA 510(k) clearance on 2019-06-07, under approval number K190503.

What company makes CeraSeal?

CeraSeal is manufactured by Meta Biomed Co., Ltd..

What is the FDA product code for CeraSeal?

The FDA product code for CeraSeal is KIF.

Other Devices by Meta Biomed Co., Ltd.

K181689Nexcomp K180802Meta P&Bond K171449Metacem K190724MD-Temp Plus K190510GuttaSil K191991Ezfil

View all 13 devices →

Related Devices (Code: KIF)

K161239MTA2.2 MATERIALAvalon Biomed, Inc. K151047MTA Repair HPAngelus Industria DE Productos Odontologicos K153067Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT XpressSybron Dental Specialties K152956Pulp Canal Sealer, Pulp Canal Sealer EWTSybron Dental Specialties K152959Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringesSybron Dental Specialties K170950Well-Root STVericom Co., Ltd.

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.

↑