Renamel Flowable Composite

Q: What is the product code of K974494?

The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.

FDA 510(k) K974494 · Cosmedent, Inc.

Substantially Equivalent

510(k) numberK974494

Submission

Device name: Renamel Flowable Composite
Applicant: Cosmedent, Inc.
Chicago, IL, US
Received: November 28, 1997
Decision date: February 10, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: EBD – Coating, Filling Material, Resin
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.3310
Specialty: Dental

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K240735	visio.lign color, visio.lign shieldEBD · Traditional	Bredent GmbH & Co. KG	12/12/2024SE
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K211854	VITA Akzent LCEBD · Traditional	Vita Zahnfabrik GmbH H Rauter & CO	11/22/2021SE
K162408	Nano Varnish, Plaquit, Lightpaint on SurfaceEBD · Traditional	Dreve Dentamid GmbH	04/05/2018SE
K163568	Shofu Resin GlazeEBD · Traditional	Shofu Dental Corporation	08/16/2017SE
K133836	Optiglaze ColorEBD · Traditional	GC America, Inc.	03/06/2014SE
K123761	Vita Enamic StainsEBD · Traditional	Innovation Meditech GmbH	03/01/2013SE
K093019	Enamelite Acryseal Spray SealantEBD · Traditional	Enamelite, LLC	12/22/2009SE

More from Enamelite, LLC

510(k)	Device	Decision
K240714	Insure® Universal; Insure® Universal AutomixEMA · Traditional	07/24/2024SE
K222435	Renamel® Microhybrid ;Renamel® Flowable MicrohybridEBF · Traditional	10/11/2022SE
K211259	Renamel BulkfillEBF · Traditional	06/24/2021SE
K172707	Renamel MicrofillEBF · Traditional	12/05/2017SE
K163480	Renamel NANO +plusEBF · Traditional	02/24/2017SE
K092730	Cosmedent Brushable CompositeEBF · Traditional	11/20/2009SE
K070583	Nano CompositeEBF · Traditional	04/16/2007SE
K060881	Temporary Crown & Bridge ResinEBG · Traditional	05/16/2006SE
K052263	Multiple (Tooth Desensitizer)LBH · Traditional	12/16/2005SE
K052501	Multiple Resin Tooth Bonding AgentKLE · Traditional	10/21/2005SE

Questions and answers

When was Renamel Flowable Composite cleared by the FDA?

Renamel Flowable Composite (K974494) received a 510(k) decision of Substantially Equivalent on February 10, 1998, 74 days after the submission was received.

What is the product code of K974494?

The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.