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FDA 510(k)

PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM

K-Number: K992518 · 1999-09-22

ApplicantDentsply Intl.
Decision Date1999-09-22
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1999-09-22 under 510(k) number K992518. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM?

PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM is a medical device that received FDA 510(k) clearance on 1999-09-22. The listed applicant is Dentsply Intl.. The 510(k) number is K992518.

When did PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM receive FDA 510(k) clearance?

PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM received FDA 510(k) clearance on 1999-09-22, under 510(k) number K992518.

Who is the listed applicant for PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM?

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 PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM?

The FDA product code for PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM is EBC.

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Related Devices (Code: EBC)

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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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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