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FDA 510(k)

SEALAPEX

K-Number: K972369 · 1997-08-15

ApplicantSybron Dental Specialties, Inc.
Decision Date1997-08-15
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SEALAPEX is the device name listed in this FDA 510(k) record. The listed applicant is Sybron Dental Specialties, Inc.. It received FDA 510(k) clearance on 1997-08-15 under 510(k) number K972369. 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 SEALAPEX?

SEALAPEX is a medical device that received FDA 510(k) clearance on 1997-08-15. The listed applicant is Sybron Dental Specialties, Inc.. The 510(k) number is K972369.

When did SEALAPEX receive FDA 510(k) clearance?

SEALAPEX received FDA 510(k) clearance on 1997-08-15, under 510(k) number K972369.

Who is the listed applicant for SEALAPEX?

The FDA 510(k) record lists Sybron Dental Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEALAPEX?

The FDA product code for SEALAPEX is KIF.

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Other records listing Sybron Dental Specialties, Inc. as applicant

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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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