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FDA 510(k)

THE GNATOMET

K-Number: K810971 · 1981-05-05

ApplicantBauer, Cheng & Associates, Inc.
Decision Date1981-05-05
Product CodeEJP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

THE GNATOMET is the device name listed in this FDA 510(k) record. The listed applicant is Bauer, Cheng & Associates, Inc.. It received FDA 510(k) clearance on 1981-05-05 under 510(k) number K810971. The device is classified under product code EJP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE GNATOMET?

THE GNATOMET is a medical device that received FDA 510(k) clearance on 1981-05-05. The listed applicant is Bauer, Cheng & Associates, Inc.. The 510(k) number is K810971.

When did THE GNATOMET receive FDA 510(k) clearance?

THE GNATOMET received FDA 510(k) clearance on 1981-05-05, under 510(k) number K810971.

Who is the listed applicant for THE GNATOMET?

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

What is the FDA product code for THE GNATOMET?

The FDA product code for THE GNATOMET is EJP.

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Other records listing Bauer, Cheng & Associates, 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: EJP)

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.

K926190ALRAND INC. (DENTAL HAND INSTRUMENTS)Alrand, Inc.K896131GNATHOMAT ARTICULATORIvoclar North America, Inc.K892373DENTAL PLASTIC BITE FORKTexapol Corp.K884418PREMIER DIE-TRAK ARTICULATORPremier MedicalK872943DISPOSABLE ARTICULATORDentsply Intl.K863009GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEXSds Dental, 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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