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FDA 510(k)

JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL

K-Number: K952614 · 1996-08-13

ApplicantDentsply Intl.
Decision Date1996-08-13
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1996-08-13 under 510(k) number K952614. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL?

JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL is a medical device that received FDA 510(k) clearance on 1996-08-13. The listed applicant is Dentsply Intl.. The 510(k) number is K952614.

When did JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL receive FDA 510(k) clearance?

JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL received FDA 510(k) clearance on 1996-08-13, under 510(k) number K952614.

Who is the listed applicant for JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL?

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 JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL?

The FDA product code for JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL is ELW.

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Related Devices (Code: ELW)

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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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