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FDA 510(k)

AQUASIL XLV SMART WETTING IMPRESSION MATERIAL

K-Number: K973782 · 1997-12-04

ApplicantDentsply Intl.
Decision Date1997-12-04
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AQUASIL XLV SMART WETTING IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1997-12-04 under 510(k) number K973782. 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 AQUASIL XLV SMART WETTING IMPRESSION MATERIAL?

AQUASIL XLV SMART WETTING IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1997-12-04. The listed applicant is Dentsply Intl.. The 510(k) number is K973782.

When did AQUASIL XLV SMART WETTING IMPRESSION MATERIAL receive FDA 510(k) clearance?

AQUASIL XLV SMART WETTING IMPRESSION MATERIAL received FDA 510(k) clearance on 1997-12-04, under 510(k) number K973782.

Who is the listed applicant for AQUASIL XLV SMART WETTING IMPRESSION MATERIAL?

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 AQUASIL XLV SMART WETTING IMPRESSION MATERIAL?

The FDA product code for AQUASIL XLV SMART WETTING IMPRESSION MATERIAL is ELW.

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Related Devices (Code: ELW)

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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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