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)

IN-CERAM SPINELL

K-Number: K951183 · 1995-05-02

ApplicantVident
Decision Date1995-05-02
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IN-CERAM SPINELL is the device name listed in this FDA 510(k) record. The listed applicant is Vident. It received FDA 510(k) clearance on 1995-05-02 under 510(k) number K951183. 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 IN-CERAM SPINELL?

IN-CERAM SPINELL is a medical device that received FDA 510(k) clearance on 1995-05-02. The listed applicant is Vident. The 510(k) number is K951183.

When did IN-CERAM SPINELL receive FDA 510(k) clearance?

IN-CERAM SPINELL received FDA 510(k) clearance on 1995-05-02, under 510(k) number K951183.

Who is the listed applicant for IN-CERAM SPINELL?

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

What is the FDA product code for IN-CERAM SPINELL?

The FDA product code for IN-CERAM SPINELL is EIH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Vident as applicant

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.

K063768TITANIUM SCALLOPED ABUTMENTK060441VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98K052710VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9,K052130VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40K050362VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES)K022996VITA IN-CERAM YZ CUBES FOR CEREC

View all 36 devices →

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.

K262074Any-ZircosMediclus Co., Ltd.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.

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.

↑