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FDA 510(k)

DENTAL AMALGAM ALLOY (SPHERICAL II)

K-Number: K760379 · 1976-08-23

ApplicantL.D. Caulk Co.
Decision Date1976-08-23
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL AMALGAM ALLOY (SPHERICAL II) is the device name listed in this FDA 510(k) record. The listed applicant is L.D. Caulk Co.. It received FDA 510(k) clearance on 1976-08-23 under 510(k) number K760379. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL AMALGAM ALLOY (SPHERICAL II)?

DENTAL AMALGAM ALLOY (SPHERICAL II) is a medical device that received FDA 510(k) clearance on 1976-08-23. The listed applicant is L.D. Caulk Co.. The 510(k) number is K760379.

When did DENTAL AMALGAM ALLOY (SPHERICAL II) receive FDA 510(k) clearance?

DENTAL AMALGAM ALLOY (SPHERICAL II) received FDA 510(k) clearance on 1976-08-23, under 510(k) number K760379.

Who is the listed applicant for DENTAL AMALGAM ALLOY (SPHERICAL II)?

The FDA 510(k) record lists L.D. Caulk Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAL AMALGAM ALLOY (SPHERICAL II)?

The FDA product code for DENTAL AMALGAM ALLOY (SPHERICAL II) is EJS.

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 L.D. Caulk 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.

K802262COMPOSITE RESTORATIVEK801690VALIANTK790586CHEMBONDK790585FINESSEK780560DENTAL AMALGAMATORK780384IMPROVED DYCAL

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Related Devices (Code: EJS)

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.

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KGK022252STERNGOLD 1, MODEL 1127781SterngoldK022469ECO E4Wieland Dental + Technik GmbH & Co. KGK021367STERNGOLD 66, MODEL #1180230SterngoldK020195SIMIDUR S1SWieland Dental + Technik GmbH & Co. KG

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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