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FDA 510(k)

SEPTOCALCINE ULTRA

K-Number: K920692 · 1992-04-21

ApplicantSpecialites Septodont
Decision Date1992-04-21
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SEPTOCALCINE ULTRA is the device name listed in this FDA 510(k) record. The listed applicant is Specialites Septodont. It received FDA 510(k) clearance on 1992-04-21 under 510(k) number K920692. 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 SEPTOCALCINE ULTRA?

SEPTOCALCINE ULTRA is a medical device that received FDA 510(k) clearance on 1992-04-21. The listed applicant is Specialites Septodont. The 510(k) number is K920692.

When did SEPTOCALCINE ULTRA receive FDA 510(k) clearance?

SEPTOCALCINE ULTRA received FDA 510(k) clearance on 1992-04-21, under 510(k) number K920692.

Who is the listed applicant for SEPTOCALCINE ULTRA?

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

What is the FDA product code for SEPTOCALCINE ULTRA?

The FDA product code for SEPTOCALCINE ULTRA is EJK.

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Other records listing Specialites Septodont 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.

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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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