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FDA 510(k)

ULTRA-ETCH STAT

K-Number: K965060 · 1997-01-31

ApplicantUltradent Products, Inc.
Decision Date1997-01-31
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRA-ETCH STAT 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 1997-01-31 under 510(k) number K965060. 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 ULTRA-ETCH STAT?

ULTRA-ETCH STAT is a medical device that received FDA 510(k) clearance on 1997-01-31. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K965060.

When did ULTRA-ETCH STAT receive FDA 510(k) clearance?

ULTRA-ETCH STAT received FDA 510(k) clearance on 1997-01-31, under 510(k) number K965060.

Who is the listed applicant for ULTRA-ETCH STAT?

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 ULTRA-ETCH STAT?

The FDA product code for ULTRA-ETCH STAT 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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