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FDA 510(k)

PERMASEAL

K-Number: K950859 · 1995-03-23

ApplicantUltradent Products, Inc.
Decision Date1995-03-23
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERMASEAL is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 1995-03-23 under 510(k) number K950859. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERMASEAL?

PERMASEAL is a medical device that received FDA 510(k) clearance on 1995-03-23. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K950859.

When did PERMASEAL receive FDA 510(k) clearance?

PERMASEAL received FDA 510(k) clearance on 1995-03-23, under 510(k) number K950859.

Who is the listed applicant for PERMASEAL?

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

What is the FDA product code for PERMASEAL?

The FDA product code for PERMASEAL is EBF.

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Other records listing Ultradent Products, Inc. as applicant

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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