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FDA 510(k)

PHOTAC-BOND

K-Number: K904096 · 1990-11-19

ApplicantEspe GmbH (Us)
Decision Date1990-11-19
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PHOTAC-BOND is the device name listed in this FDA 510(k) record. The listed applicant is Espe GmbH (Us). It received FDA 510(k) clearance on 1990-11-19 under 510(k) number K904096. 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 PHOTAC-BOND?

PHOTAC-BOND is a medical device that received FDA 510(k) clearance on 1990-11-19. The listed applicant is Espe GmbH (Us). The 510(k) number is K904096.

When did PHOTAC-BOND receive FDA 510(k) clearance?

PHOTAC-BOND received FDA 510(k) clearance on 1990-11-19, under 510(k) number K904096.

Who is the listed applicant for PHOTAC-BOND?

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

What is the FDA product code for PHOTAC-BOND?

The FDA product code for PHOTAC-BOND is EJK.

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Other records listing Espe GmbH (Us) 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.

K925027PHOTAC-FIL APLICAPK913966SONO(R) -CEMK915005PHOTAC-BOND APLICAP, MODIFICATIONK913857ROCATEC(R) -PLUSK913965ESPE(R) -SILK905604VISIO-GEM ART-SYSTEM

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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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