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FDA 510(k)

OPTIFLOW II FLOWABLE COMPOSITE, LC

K-Number: K130672 · 2013-08-13

ApplicantPac-Dent International, Inc.
Decision Date2013-08-13
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTIFLOW II FLOWABLE COMPOSITE, LC is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent International, Inc.. It received FDA 510(k) clearance on 2013-08-13 under 510(k) number K130672. 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 OPTIFLOW II FLOWABLE COMPOSITE, LC?

OPTIFLOW II FLOWABLE COMPOSITE, LC is a medical device that received FDA 510(k) clearance on 2013-08-13. The listed applicant is Pac-Dent International, Inc.. The 510(k) number is K130672.

When did OPTIFLOW II FLOWABLE COMPOSITE, LC receive FDA 510(k) clearance?

OPTIFLOW II FLOWABLE COMPOSITE, LC received FDA 510(k) clearance on 2013-08-13, under 510(k) number K130672.

Who is the listed applicant for OPTIFLOW II FLOWABLE COMPOSITE, LC?

The FDA 510(k) record lists Pac-Dent International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTIFLOW II FLOWABLE COMPOSITE, LC?

The FDA product code for OPTIFLOW II FLOWABLE COMPOSITE, LC is EBF.

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Other records listing Pac-Dent International, Inc. 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.

K162662GingiDent Gingival Retraction PasteK160577PacEndo ChlorhexidineK151123Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier FilmK153528PacEndo EDTA

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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