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FDA 510(k)

REOLIT

K-Number: K802685 · 1980-11-12

ApplicantVivadent (Usa), Inc.
Decision Date1980-11-12
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REOLIT is the device name listed in this FDA 510(k) record. The listed applicant is Vivadent (Usa), Inc.. It received FDA 510(k) clearance on 1980-11-12 under 510(k) number K802685. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REOLIT?

REOLIT is a medical device that received FDA 510(k) clearance on 1980-11-12. The listed applicant is Vivadent (Usa), Inc.. The 510(k) number is K802685.

When did REOLIT receive FDA 510(k) clearance?

REOLIT received FDA 510(k) clearance on 1980-11-12, under 510(k) number K802685.

Who is the listed applicant for REOLIT?

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

What is the FDA product code for REOLIT?

The FDA product code for REOLIT is EJK.

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Other records listing Vivadent (Usa), 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.

K863831VIVADENT FILPINK823409HELIOSIT-ORTHODONTICK813015HELIOSEALK802679SILANITK802682CONTACT SEALK802684HELIOMAT

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Related Devices (Code: EJK)

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.

K261728One-Fil LCMediclus Co., Ltd.K253248Bright Cavity LinerDmp Dental Industry S.A.K2302703M™ VitCal Liner/Base3M Espe Dental ProductsK212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro LimitedK201799CleaniCalMaruchiK202413LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten 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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