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FDA 510(k)

MERIDIAN

K-Number: K131753 · 2013-11-14

ApplicantAb Ardent
Decision Date2013-11-14
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MERIDIAN is the device name listed in this FDA 510(k) record. The listed applicant is Ab Ardent. It received FDA 510(k) clearance on 2013-11-14 under 510(k) number K131753. 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 MERIDIAN?

MERIDIAN is a medical device that received FDA 510(k) clearance on 2013-11-14. The listed applicant is Ab Ardent. The 510(k) number is K131753.

When did MERIDIAN receive FDA 510(k) clearance?

MERIDIAN received FDA 510(k) clearance on 2013-11-14, under 510(k) number K131753.

Who is the listed applicant for MERIDIAN?

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

What is the FDA product code for MERIDIAN?

The FDA product code for MERIDIAN is EBF.

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Other records listing Ab Ardent 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.

K040465LATIT FLOWK022971MICROHYBRID 11K022973ADHESIVE 14K022972MICROFILL 13K022975ETCHING 15K022974MICROHYBRID 12

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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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