BA Pit & Fissure Sealant
K-Number: K190998 · 2019-11-08
ApplicantApex Dental Materials, Inc.
Decision Date2019-11-08
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
BA Pit & Fissure Sealant is a medical device manufactured by Apex Dental Materials, Inc.. It received FDA 510(k) clearance on 2019-11-08 under approval number K190998. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BA Pit & Fissure Sealant?
BA Pit & Fissure Sealant is a medical device that received FDA 510(k) clearance on 2019-11-08. It is manufactured by Apex Dental Materials, Inc.. The 510(k) number is K190998.
When was BA Pit & Fissure Sealant approved by the FDA?
BA Pit & Fissure Sealant received FDA 510(k) clearance on 2019-11-08, under approval number K190998.
What company makes BA Pit & Fissure Sealant?
BA Pit & Fissure Sealant is manufactured by Apex Dental Materials, Inc..
What is the FDA product code for BA Pit & Fissure Sealant?
The FDA product code for BA Pit & Fissure Sealant is EBC.
Other Devices by Apex Dental Materials, Inc.
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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.