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FDA 510(k)

WAX BITE IMPRESSION WAFER

K-Number: K850915 · 1985-04-16

ApplicantToothprints, Inc.
Decision Date1985-04-16
Product CodeEGD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

WAX BITE IMPRESSION WAFER is the device name listed in this FDA 510(k) record. The listed applicant is Toothprints, Inc.. It received FDA 510(k) clearance on 1985-04-16 under 510(k) number K850915. The device is classified under product code EGD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAX BITE IMPRESSION WAFER?

WAX BITE IMPRESSION WAFER is a medical device that received FDA 510(k) clearance on 1985-04-16. The listed applicant is Toothprints, Inc.. The 510(k) number is K850915.

When did WAX BITE IMPRESSION WAFER receive FDA 510(k) clearance?

WAX BITE IMPRESSION WAFER received FDA 510(k) clearance on 1985-04-16, under 510(k) number K850915.

Who is the listed applicant for WAX BITE IMPRESSION WAFER?

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

What is the FDA product code for WAX BITE IMPRESSION WAFER?

The FDA product code for WAX BITE IMPRESSION WAFER is EGD.

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Related Devices (Code: EGD)

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.

K020009BRACE EZEUdent, Inc.K945535GLENROE ORTHO-SILGlenroe TechnologiesK924024ORTHO WAXHeraeus Kulzer, Inc.K923586BURNOUT MATERIALDentsply Intl.K914892SALIVA-STIMOrion Diagnostica, Inc.K922380BITE RIM WAXDentsply Intl.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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