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FDA 510(k)

CERAMIC PEDATRIC PREFORMED CROWN

K-Number: K091362 · 2009-06-29

ApplicantEz-Pedo, Inc.
Decision Date2009-06-29
Product CodeELZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERAMIC PEDATRIC PREFORMED CROWN is the device name listed in this FDA 510(k) record. The listed applicant is Ez-Pedo, Inc.. It received FDA 510(k) clearance on 2009-06-29 under 510(k) number K091362. 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 CERAMIC PEDATRIC PREFORMED CROWN?

CERAMIC PEDATRIC PREFORMED CROWN is a medical device that received FDA 510(k) clearance on 2009-06-29. The listed applicant is Ez-Pedo, Inc.. The 510(k) number is K091362.

When did CERAMIC PEDATRIC PREFORMED CROWN receive FDA 510(k) clearance?

CERAMIC PEDATRIC PREFORMED CROWN received FDA 510(k) clearance on 2009-06-29, under 510(k) number K091362.

Who is the listed applicant for CERAMIC PEDATRIC PREFORMED CROWN?

The FDA 510(k) record lists Ez-Pedo, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CERAMIC PEDATRIC PREFORMED CROWN?

The FDA product code for CERAMIC PEDATRIC PREFORMED CROWN is ELZ.

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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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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.

K932759TEMPOARY POLYCARBONATE CROWNSSouth American Dental Exporting Corp.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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