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FDA 510(k)

TEMPOARY POLYCARBONATE CROWNS

K-Number: K932759 · 1994-07-22

ApplicantSouth American Dental Exporting Corp.
Decision Date1994-07-22
Product CodeELZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMPOARY POLYCARBONATE CROWNS is the device name listed in this FDA 510(k) record. The listed applicant is South American Dental Exporting Corp.. It received FDA 510(k) clearance on 1994-07-22 under 510(k) number K932759. The device is classified under product code ELZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEMPOARY POLYCARBONATE CROWNS?

TEMPOARY POLYCARBONATE CROWNS is a medical device that received FDA 510(k) clearance on 1994-07-22. The listed applicant is South American Dental Exporting Corp.. The 510(k) number is K932759.

When did TEMPOARY POLYCARBONATE CROWNS receive FDA 510(k) clearance?

TEMPOARY POLYCARBONATE CROWNS received FDA 510(k) clearance on 1994-07-22, under 510(k) number K932759.

Who is the listed applicant for TEMPOARY POLYCARBONATE CROWNS?

The FDA 510(k) record lists South American Dental Exporting Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEMPOARY POLYCARBONATE CROWNS?

The FDA product code for TEMPOARY POLYCARBONATE CROWNS is ELZ.

Related Clinical Trials

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Related Devices (Code: ELZ)

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.

K091362CERAMIC PEDATRIC PREFORMED CROWNEz-Pedo, Inc.K931352PEDO JACKETS OR PJ'SGeorge M. Wilson, DdsK913152WHITER BITER CROWNGeorge M. Wilson, DdsK912686WHITER BITER CROWNGeorge M. Wilson, DdsK892893SDI POLYCARBONATE CROWN, SCHEIN'SSvenska Dental Instruments ABK883325PERFORMED CROWN (STAINLESS STEEL)Whitecap Dental Co.

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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