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FDA 510(k)

DENTAL ENDODONTIC CEMENT (MODIFICATION)

K-Number: K894092 · 1990-01-10

ApplicantThe Hygenic Corp.
Decision Date1990-01-10
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL ENDODONTIC CEMENT (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is The Hygenic Corp.. It received FDA 510(k) clearance on 1990-01-10 under 510(k) number K894092. 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 DENTAL ENDODONTIC CEMENT (MODIFICATION)?

DENTAL ENDODONTIC CEMENT (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1990-01-10. The listed applicant is The Hygenic Corp.. The 510(k) number is K894092.

When did DENTAL ENDODONTIC CEMENT (MODIFICATION) receive FDA 510(k) clearance?

DENTAL ENDODONTIC CEMENT (MODIFICATION) received FDA 510(k) clearance on 1990-01-10, under 510(k) number K894092.

Who is the listed applicant for DENTAL ENDODONTIC CEMENT (MODIFICATION)?

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

What is the FDA product code for DENTAL ENDODONTIC CEMENT (MODIFICATION)?

The FDA product code for DENTAL ENDODONTIC CEMENT (MODIFICATION) is KIF.

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Other records listing The Hygenic Corp. 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.

K954990DENTAL DAMK930764ENDO-ICE-PULP TESTER-THERMALK905418GATES GLIDDEN DRILLSK911225TRAY DOUGHK905640SOLID CORE GUTTA PERCHA CARRIERK900301NOVUS BONDING AGENT

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Related Devices (Code: KIF)

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.

K262050Vioseal XSpident Co., Ltd.K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.K261514Calcium Hydroxide Temporary Filling Material (KP-Cal)Guilin Kevin Peter Technology Co., Ltd.K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.K253167Any-PasteMediclus Co., Ltd.K252890ZenSeal ProKerr Corporation

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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