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FDA 510(k)

PHOTO CLEARFIL OPAQUER

K-Number: K860708 · 1986-04-17

ApplicantKuraray Co.
Decision Date1986-04-17
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PHOTO CLEARFIL OPAQUER is the device name listed in this FDA 510(k) record. The listed applicant is Kuraray Co.. It received FDA 510(k) clearance on 1986-04-17 under 510(k) number K860708. 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 PHOTO CLEARFIL OPAQUER?

PHOTO CLEARFIL OPAQUER is a medical device that received FDA 510(k) clearance on 1986-04-17. The listed applicant is Kuraray Co.. The 510(k) number is K860708.

When did PHOTO CLEARFIL OPAQUER receive FDA 510(k) clearance?

PHOTO CLEARFIL OPAQUER received FDA 510(k) clearance on 1986-04-17, under 510(k) number K860708.

Who is the listed applicant for PHOTO CLEARFIL OPAQUER?

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

What is the FDA product code for PHOTO CLEARFIL OPAQUER?

The FDA product code for PHOTO CLEARFIL OPAQUER is EBF.

Related Clinical Trials

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.

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Other records listing Kuraray Co. 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.

K990040CLEARFIL SE BONDK951813CARIES DETECTORK933030PANAVIA 21K925383PHOTO CLEARFIL OPAQUERK925404CLEARFIL PORCELAIN BOND ACTIVATORK912707CLEARFIL LINER BOND SYSTEM

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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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