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FDA 510(k)

HYDROPHILIC REPROSIL

K-Number: K863288 · 1986-12-01

ApplicantDentsply Intl.
Decision Date1986-12-01
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDROPHILIC REPROSIL is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1986-12-01 under 510(k) number K863288. 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 HYDROPHILIC REPROSIL?

HYDROPHILIC REPROSIL is a medical device that received FDA 510(k) clearance on 1986-12-01. The listed applicant is Dentsply Intl.. The 510(k) number is K863288.

When did HYDROPHILIC REPROSIL receive FDA 510(k) clearance?

HYDROPHILIC REPROSIL received FDA 510(k) clearance on 1986-12-01, under 510(k) number K863288.

Who is the listed applicant for HYDROPHILIC REPROSIL?

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

What is the FDA product code for HYDROPHILIC REPROSIL?

The FDA product code for HYDROPHILIC REPROSIL is ELW.

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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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