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FDA 510(k)

ISOSIT TEETH

K-Number: K810970 · 1981-05-05

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

Device Summary

ISOSIT TEETH 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 K810970. The device is classified under product code ELM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOSIT TEETH?

ISOSIT TEETH 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 K810970.

When did ISOSIT TEETH receive FDA 510(k) clearance?

ISOSIT TEETH received FDA 510(k) clearance on 1981-05-05, under 510(k) number K810970.

Who is the listed applicant for ISOSIT TEETH?

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 ISOSIT TEETH?

The FDA product code for ISOSIT TEETH is ELM.

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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.

K840084COLTENE BRILLIANT LUXK840085COLTENE BRILLIANTK823100RX 91K823098REX-CAPSK823097NATURELLEK823084CHALLENGER

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Related Devices (Code: ELM)

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.

K122955DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUMWright Health Group , Ltd.K122925NEW STETIC ARTIFICIAL TEETHNew SteticK122852PHYSIOSTAR NFCCandulor USA, Inc.K121749VERACIAShofu Dental CorporationK120404MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETHMerz Dental GmbHK120736SR PHONARES IIIvoclar Vivadent, AG

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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