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FDA 510(k)

KERAMAIL

K-Number: K915653 · 1993-04-08

ApplicantWilde-USA, Inc.
Decision Date1993-04-08
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KERAMAIL is the device name listed in this FDA 510(k) record. The listed applicant is Wilde-USA, Inc.. It received FDA 510(k) clearance on 1993-04-08 under 510(k) number K915653. 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 KERAMAIL?

KERAMAIL is a medical device that received FDA 510(k) clearance on 1993-04-08. The listed applicant is Wilde-USA, Inc.. The 510(k) number is K915653.

When did KERAMAIL receive FDA 510(k) clearance?

KERAMAIL received FDA 510(k) clearance on 1993-04-08, under 510(k) number K915653.

Who is the listed applicant for KERAMAIL?

The FDA 510(k) record lists Wilde-USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KERAMAIL?

The FDA product code for KERAMAIL is EIH.

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Other records listing Wilde-USA, Inc. 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.

K913582COMPATIT RK913581WILDE ADHESIVE BONDING SYSTEMK923472COMPACOLORK920649COMPASEPK915250WIL-PDS & WIL-PDI CASTING ALLOYSK913089WILDE LIGHT CURING COMPOSITE RESTORATIVE RESINS

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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.

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