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FDA 510(k)

INJECTAFIL

K-Number: K091647 · 2009-09-21

ApplicantApex Dental Materials, Inc.
Decision Date2009-09-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INJECTAFIL is the device name listed in this FDA 510(k) record. The listed applicant is Apex Dental Materials, Inc.. It received FDA 510(k) clearance on 2009-09-21 under 510(k) number K091647. 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 INJECTAFIL?

INJECTAFIL is a medical device that received FDA 510(k) clearance on 2009-09-21. The listed applicant is Apex Dental Materials, Inc.. The 510(k) number is K091647.

When did INJECTAFIL receive FDA 510(k) clearance?

INJECTAFIL received FDA 510(k) clearance on 2009-09-21, under 510(k) number K091647.

Who is the listed applicant for INJECTAFIL?

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

What is the FDA product code for INJECTAFIL?

The FDA product code for INJECTAFIL is EBF.

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Other records listing Apex Dental Materials, 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.

K190998BA Pit & Fissure SealantK161077RnD TE and RnD SEK131043APEX UNIVERSAL ADHESIVEK131049ZRPK120620CLEAN AND BOOSTK110859METAL OPAQUER

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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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