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FDA 510(k)

STER-MATE STERILE LAVAGE KIT

K-Number: K082973 · 2009-01-29

ApplicantDentsply Interntional
Decision Date2009-01-29
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STER-MATE STERILE LAVAGE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Interntional. It received FDA 510(k) clearance on 2009-01-29 under 510(k) number K082973. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STER-MATE STERILE LAVAGE KIT?

STER-MATE STERILE LAVAGE KIT is a medical device that received FDA 510(k) clearance on 2009-01-29. The listed applicant is Dentsply Interntional. The 510(k) number is K082973.

When did STER-MATE STERILE LAVAGE KIT receive FDA 510(k) clearance?

STER-MATE STERILE LAVAGE KIT received FDA 510(k) clearance on 2009-01-29, under 510(k) number K082973.

Who is the listed applicant for STER-MATE STERILE LAVAGE KIT?

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

What is the FDA product code for STER-MATE STERILE LAVAGE KIT?

The FDA product code for STER-MATE STERILE LAVAGE KIT is ELC.

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K092614X-SMART EASYK092030ELATION MB METAL REINFORCED PLASTIC BRACKETK090454ALLURE MB CERAMIC BRACKETSK082974MYSTIQUE MB CERAMIC BRACKETSK081291PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSIONK080311MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM

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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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