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

FDA 510(k)

UltraThineer Zirconia Slurry (5Y-B)

K-Number: K240419 · 2024-04-12

ApplicantBoston Micro Fabrication
Decision Date2024-04-12
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UltraThineer Zirconia Slurry (5Y-B) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Micro Fabrication. It received FDA 510(k) clearance on 2024-04-12 under 510(k) number K240419. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UltraThineer Zirconia Slurry (5Y-B)?

UltraThineer Zirconia Slurry (5Y-B) is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Boston Micro Fabrication. The 510(k) number is K240419.

When did UltraThineer Zirconia Slurry (5Y-B) receive FDA 510(k) clearance?

UltraThineer Zirconia Slurry (5Y-B) received FDA 510(k) clearance on 2024-04-12, under 510(k) number K240419.

Who is the listed applicant for UltraThineer Zirconia Slurry (5Y-B)?

The FDA 510(k) record lists Boston Micro Fabrication as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraThineer Zirconia Slurry (5Y-B)?

The FDA product code for UltraThineer Zirconia Slurry (5Y-B) is EIH.

Related Devices (Code: EIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.K253191DCMhotbond zirconDental Creativ Management GmbH

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.

↑