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FDA 510(k)

DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.

K-Number: K883842 · 1989-03-17

ApplicantDentsply Intl.
Decision Date1989-03-17
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI. is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1989-03-17 under 510(k) number K883842. 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 DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.?

DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI. is a medical device that received FDA 510(k) clearance on 1989-03-17. The listed applicant is Dentsply Intl.. The 510(k) number is K883842.

When did DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI. receive FDA 510(k) clearance?

DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI. received FDA 510(k) clearance on 1989-03-17, under 510(k) number K883842.

Who is the listed applicant for DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.?

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 DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.?

The FDA product code for DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI. 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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