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FDA 510(k)

PERMADYNE PENTA (HIGH & LOW VISCOSITY)

K-Number: K953027 · 1995-07-19

ApplicantEspe GmbH & Co. Kg.
Decision Date1995-07-19
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERMADYNE PENTA (HIGH & LOW VISCOSITY) is the device name listed in this FDA 510(k) record. The listed applicant is Espe GmbH & Co. Kg.. It received FDA 510(k) clearance on 1995-07-19 under 510(k) number K953027. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERMADYNE PENTA (HIGH & LOW VISCOSITY)?

PERMADYNE PENTA (HIGH & LOW VISCOSITY) is a medical device that received FDA 510(k) clearance on 1995-07-19. The listed applicant is Espe GmbH & Co. Kg.. The 510(k) number is K953027.

When did PERMADYNE PENTA (HIGH & LOW VISCOSITY) receive FDA 510(k) clearance?

PERMADYNE PENTA (HIGH & LOW VISCOSITY) received FDA 510(k) clearance on 1995-07-19, under 510(k) number K953027.

Who is the listed applicant for PERMADYNE PENTA (HIGH & LOW VISCOSITY)?

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

What is the FDA product code for PERMADYNE PENTA (HIGH & LOW VISCOSITY)?

The FDA product code for PERMADYNE PENTA (HIGH & LOW VISCOSITY) is ELW.

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Other records listing Espe GmbH & Co. Kg. 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.

K974231POSITION PENTA, POSITION PENTA QUICKK973513SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUERK973262KETAC-FIL APLICAP PLUSK972892CAVIT-LCK963735COJET SYSTEMK963737HYCEM APLICAP

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Related Devices (Code: ELW)

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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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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