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FDA 510(k)

CALCIPULPE

K-Number: K760659 · 1976-09-27

ApplicantSeptodont, Inc.
Decision Date1976-09-27
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CALCIPULPE is the device name listed in this FDA 510(k) record. The listed applicant is Septodont, Inc.. It received FDA 510(k) clearance on 1976-09-27 under 510(k) number K760659. 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 CALCIPULPE?

CALCIPULPE is a medical device that received FDA 510(k) clearance on 1976-09-27. The listed applicant is Septodont, Inc.. The 510(k) number is K760659.

When did CALCIPULPE receive FDA 510(k) clearance?

CALCIPULPE received FDA 510(k) clearance on 1976-09-27, under 510(k) number K760659.

Who is the listed applicant for CALCIPULPE?

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

What is the FDA product code for CALCIPULPE?

The FDA product code for CALCIPULPE is EJK.

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Other records listing Septodont, 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.

K780003ENDOSOLV EK771114NEUTROCIMK761354CIMPAT (PINK AND WHITE)K761355SELFASTK760798FLUOCAL GEL MINTK760799FLUOCAL GEL ORANGE

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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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