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FDA 510(k)

RENAMEL ESTHETIC RESTORATIVE SYSTEM

K-Number: K854755 · 1986-03-13

ApplicantCosmedent, Inc.
Decision Date1986-03-13
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RENAMEL ESTHETIC RESTORATIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cosmedent, Inc.. It received FDA 510(k) clearance on 1986-03-13 under 510(k) number K854755. 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 RENAMEL ESTHETIC RESTORATIVE SYSTEM?

RENAMEL ESTHETIC RESTORATIVE SYSTEM is a medical device that received FDA 510(k) clearance on 1986-03-13. The listed applicant is Cosmedent, Inc.. The 510(k) number is K854755.

When did RENAMEL ESTHETIC RESTORATIVE SYSTEM receive FDA 510(k) clearance?

RENAMEL ESTHETIC RESTORATIVE SYSTEM received FDA 510(k) clearance on 1986-03-13, under 510(k) number K854755.

Who is the listed applicant for RENAMEL ESTHETIC RESTORATIVE SYSTEM?

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

What is the FDA product code for RENAMEL ESTHETIC RESTORATIVE SYSTEM?

The FDA product code for RENAMEL ESTHETIC RESTORATIVE SYSTEM is EBF.

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Other records listing Cosmedent, 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.

K240714Insure® Universal; Insure® Universal AutomixK222435Renamel® Microhybrid ;Renamel® Flowable MicrohybridK211259Renamel BulkfillK172707Renamel MicrofillK163480Renamel NANO +plusK092730COSMEDENT BRUSHABLE COMPOSITE

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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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