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FDA 510(k)

IMPREFLEX ALGINATE IMPRESSION MATERIAL

K-Number: K771120 · 1977-08-03

ApplicantEspe Dental Products
Decision Date1977-08-03
Product CodeLEW
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IMPREFLEX ALGINATE IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Espe Dental Products. It received FDA 510(k) clearance on 1977-08-03 under 510(k) number K771120. The device is classified under product code LEW. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMPREFLEX ALGINATE IMPRESSION MATERIAL?

IMPREFLEX ALGINATE IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 1977-08-03. The listed applicant is Espe Dental Products. The 510(k) number is K771120.

When did IMPREFLEX ALGINATE IMPRESSION MATERIAL receive FDA 510(k) clearance?

IMPREFLEX ALGINATE IMPRESSION MATERIAL received FDA 510(k) clearance on 1977-08-03, under 510(k) number K771120.

Who is the listed applicant for IMPREFLEX ALGINATE IMPRESSION MATERIAL?

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

What is the FDA product code for IMPREFLEX ALGINATE IMPRESSION MATERIAL?

The FDA product code for IMPREFLEX ALGINATE IMPRESSION MATERIAL is LEW.

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Other records listing Espe Dental Products 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.

K810950VISIO-SEALK802819KETAC-CEM IN REF. TO K802048K802049NIMETIC-DISPERSK800031PERMADYNE POLYETHER RUBBER IMPRESSIONK771889UNIOLITEK771901CAPMIX

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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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