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FDA 510(k)

CROWN & BRIDGE RESIN

K-Number: K834435 · 1984-02-21

ApplicantRohm and Haas Co.
Decision Date1984-02-21
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CROWN & BRIDGE RESIN is the device name listed in this FDA 510(k) record. The listed applicant is Rohm and Haas Co.. It received FDA 510(k) clearance on 1984-02-21 under 510(k) number K834435. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CROWN & BRIDGE RESIN?

CROWN & BRIDGE RESIN is a medical device that received FDA 510(k) clearance on 1984-02-21. The listed applicant is Rohm and Haas Co.. The 510(k) number is K834435.

When did CROWN & BRIDGE RESIN receive FDA 510(k) clearance?

CROWN & BRIDGE RESIN received FDA 510(k) clearance on 1984-02-21, under 510(k) number K834435.

Who is the listed applicant for CROWN & BRIDGE RESIN?

The FDA 510(k) record lists Rohm and Haas Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CROWN & BRIDGE RESIN?

The FDA product code for CROWN & BRIDGE RESIN is EBI.

Related Clinical Trials

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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Other records listing Rohm and Haas Co. 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.

K911299EQUIPMENT/MATERIAL DECONTAMINATING KITK822722CROWN S BRIDGE RESINK820456CROWN & BRIDGE RESIN FOR FABRICAT/DE

Related Devices (Code: EBI)

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.

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.

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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