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FDA 510(k)

TENAX WHITE POST

K-Number: K993545 · 2000-04-14

ApplicantColtene/Whaledent, Inc.
Decision Date2000-04-14
Product CodeELR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TENAX WHITE POST is the device name listed in this FDA 510(k) record. The listed applicant is Coltene/Whaledent, Inc.. It received FDA 510(k) clearance on 2000-04-14 under 510(k) number K993545. The device is classified under product code ELR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENAX WHITE POST?

TENAX WHITE POST is a medical device that received FDA 510(k) clearance on 2000-04-14. The listed applicant is Coltene/Whaledent, Inc.. The 510(k) number is K993545.

When did TENAX WHITE POST receive FDA 510(k) clearance?

TENAX WHITE POST received FDA 510(k) clearance on 2000-04-14, under 510(k) number K993545.

Who is the listed applicant for TENAX WHITE POST?

The FDA 510(k) record lists Coltene/Whaledent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENAX WHITE POST?

The FDA product code for TENAX WHITE POST is ELR.

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Other records listing Coltene/Whaledent, Inc. as applicant

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Related Devices (Code: ELR)

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.

K060075FIBER-METAL POSTForemost Dental, LLCK042848FRC POSTEC PLUSIvoclar Vivadent, Inc.K030820EVERSTICK POSTStick Tech , Ltd.K020431FIBIOCOREEst. AnthogyrK012496CARBON POSTJ. Morita USA, Inc.K013802FRC POSTECIvoclar Vivadent, Inc.

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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