DIA-ROOT BIO MTA
K-Number: K200174 · 2020-09-18
ApplicantDiaDent Group International
Decision Date2020-09-18
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
DIA-ROOT BIO MTA is a medical device manufactured by DiaDent Group International. It received FDA 510(k) clearance on 2020-09-18 under approval number K200174. 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 DIA-ROOT BIO MTA?
DIA-ROOT BIO MTA is a medical device that received FDA 510(k) clearance on 2020-09-18. It is manufactured by DiaDent Group International. The 510(k) number is K200174.
When was DIA-ROOT BIO MTA approved by the FDA?
DIA-ROOT BIO MTA received FDA 510(k) clearance on 2020-09-18, under approval number K200174.
What company makes DIA-ROOT BIO MTA?
DIA-ROOT BIO MTA is manufactured by DiaDent Group International.
What is the FDA product code for DIA-ROOT BIO MTA?
The FDA product code for DIA-ROOT BIO MTA is KIF.
Other Devices by DiaDent Group International
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.