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FDA 510(k)

ULTRACROWN(TM) PD DENTAL ALLOY

K-Number: K913232 · 1991-09-06

ApplicantDentsply Intl.
Decision Date1991-09-06
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ULTRACROWN(TM) PD DENTAL ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1991-09-06 under 510(k) number K913232. 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 ULTRACROWN(TM) PD DENTAL ALLOY?

ULTRACROWN(TM) PD DENTAL ALLOY is a medical device that received FDA 510(k) clearance on 1991-09-06. The listed applicant is Dentsply Intl.. The 510(k) number is K913232.

When did ULTRACROWN(TM) PD DENTAL ALLOY receive FDA 510(k) clearance?

ULTRACROWN(TM) PD DENTAL ALLOY received FDA 510(k) clearance on 1991-09-06, under 510(k) number K913232.

Who is the listed applicant for ULTRACROWN(TM) PD DENTAL ALLOY?

The FDA 510(k) record lists Dentsply Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRACROWN(TM) PD DENTAL ALLOY?

The FDA product code for ULTRACROWN(TM) PD DENTAL ALLOY is EJS.

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Other records listing Dentsply Intl. as applicant

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K123615IRIS - HIGH STRENGTH GLASS CERAMICK072730FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTSK070538XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVEK070019CARRARA VOLUMIAK061427PRE-IMPRESSION CONDITIONING SOLUTIONK052334CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131

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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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