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FDA 510(k)

PARAPOST XT SYSTEM

K-Number: K934192 · 1994-06-06

ApplicantColtene/Whaledent, Inc.
Decision Date1994-06-06
Product CodeELR
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PARAPOST XT SYSTEM 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 1994-06-06 under 510(k) number K934192. 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 PARAPOST XT SYSTEM?

PARAPOST XT SYSTEM is a medical device that received FDA 510(k) clearance on 1994-06-06. The listed applicant is Coltene/Whaledent, Inc.. The 510(k) number is K934192.

When did PARAPOST XT SYSTEM receive FDA 510(k) clearance?

PARAPOST XT SYSTEM received FDA 510(k) clearance on 1994-06-06, under 510(k) number K934192.

Who is the listed applicant for PARAPOST XT SYSTEM?

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 PARAPOST XT SYSTEM?

The FDA product code for PARAPOST XT SYSTEM is ELR.

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Other records listing Coltene/Whaledent, Inc. as applicant

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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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.

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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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