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FDA 510(k)

CORE-IDE

K-Number: K984037 · 1999-02-04

ApplicantRoydent Dental Products, Inc.
Decision Date1999-02-04
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CORE-IDE is the device name listed in this FDA 510(k) record. The listed applicant is Roydent Dental Products, Inc.. It received FDA 510(k) clearance on 1999-02-04 under 510(k) number K984037. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORE-IDE?

CORE-IDE is a medical device that received FDA 510(k) clearance on 1999-02-04. The listed applicant is Roydent Dental Products, Inc.. The 510(k) number is K984037.

When did CORE-IDE receive FDA 510(k) clearance?

CORE-IDE received FDA 510(k) clearance on 1999-02-04, under 510(k) number K984037.

Who is the listed applicant for CORE-IDE?

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

What is the FDA product code for CORE-IDE?

The FDA product code for CORE-IDE is EBD.

Other records listing Roydent Dental Products, 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.

K983357MUCOPREN SOFT RELINING SYSTEMK954281PANASIL IMPRESSION MATERIAL

Related Devices (Code: EBD)

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.

K254091GLOSSY COAT (15ML)YAMAHACHI DENTAL MFG., Co.K250804ID LIGHT CURE SYSTEMId Korea Co., Ltd.K240735visio.lign color, visio.lign shieldBredent GmbH & Co. KGK223365RODIN Palette Naturalizing KitBelport Company, Inc., Gingi-PakK211854VITA Akzent LCVita Zahnfabrik GmbH H Rauter & COK162408Nano Varnish, Plaquit, Lightpaint on SurfaceDreve Dentamid GmbH

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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