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FDA 510(k)

EMBRACE DUAL CURE COMPOSITE MATERIALS

K-Number: K071278 · 2007-06-29

ApplicantPulpdent Corporation
Decision Date2007-06-29
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EMBRACE DUAL CURE COMPOSITE MATERIALS is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2007-06-29 under 510(k) number K071278. 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 EMBRACE DUAL CURE COMPOSITE MATERIALS?

EMBRACE DUAL CURE COMPOSITE MATERIALS is a medical device that received FDA 510(k) clearance on 2007-06-29. The listed applicant is Pulpdent Corporation. The 510(k) number is K071278.

When did EMBRACE DUAL CURE COMPOSITE MATERIALS receive FDA 510(k) clearance?

EMBRACE DUAL CURE COMPOSITE MATERIALS received FDA 510(k) clearance on 2007-06-29, under 510(k) number K071278.

Who is the listed applicant for EMBRACE DUAL CURE COMPOSITE MATERIALS?

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

What is the FDA product code for EMBRACE DUAL CURE COMPOSITE MATERIALS?

The FDA product code for EMBRACE DUAL CURE COMPOSITE MATERIALS is EBF.

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Other records listing Pulpdent Corporation 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.

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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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