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FDA 510(k)

CROWN, ACRYLIC, CORAL BRAND, PREFORMED

K-Number: K770684 · 1977-04-26

ApplicantParker Laboratories, Inc.
Decision Date1977-04-26
Product CodeELZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CROWN, ACRYLIC, CORAL BRAND, PREFORMED is the device name listed in this FDA 510(k) record. The listed applicant is Parker Laboratories, Inc.. It received FDA 510(k) clearance on 1977-04-26 under 510(k) number K770684. 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 CROWN, ACRYLIC, CORAL BRAND, PREFORMED?

CROWN, ACRYLIC, CORAL BRAND, PREFORMED is a medical device that received FDA 510(k) clearance on 1977-04-26. The listed applicant is Parker Laboratories, Inc.. The 510(k) number is K770684.

When did CROWN, ACRYLIC, CORAL BRAND, PREFORMED receive FDA 510(k) clearance?

CROWN, ACRYLIC, CORAL BRAND, PREFORMED received FDA 510(k) clearance on 1977-04-26, under 510(k) number K770684.

Who is the listed applicant for CROWN, ACRYLIC, CORAL BRAND, PREFORMED?

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

What is the FDA product code for CROWN, ACRYLIC, CORAL BRAND, PREFORMED?

The FDA product code for CROWN, ACRYLIC, CORAL BRAND, PREFORMED is ELZ.

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Other records listing Parker Laboratories, Inc. as applicant

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K233965UltraDrape UGPIV Barrier and Securement (34-15)K953673ECLIPSE PROBE COVERK921695ULTRA COVER ULTRASOUND TRANSDUCER PROBE COVERSK864556AQUALUBE(TM)K861239ACRYLIC SOLDERK855167DYNA SYSTEM

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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.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 AB

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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