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FDA 510(k)

O BUTMENT

K-Number: K903211 · 1991-03-29

ApplicantO Co., Inc.
Decision Date1991-03-29
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

O BUTMENT is the device name listed in this FDA 510(k) record. The listed applicant is O Co., Inc.. It received FDA 510(k) clearance on 1991-03-29 under 510(k) number K903211. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O BUTMENT?

O BUTMENT is a medical device that received FDA 510(k) clearance on 1991-03-29. The listed applicant is O Co., Inc.. The 510(k) number is K903211.

When did O BUTMENT receive FDA 510(k) clearance?

O BUTMENT received FDA 510(k) clearance on 1991-03-29, under 510(k) number K903211.

Who is the listed applicant for O BUTMENT?

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

What is the FDA product code for O BUTMENT?

The FDA product code for O BUTMENT is DZE.

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Other records listing O Co., 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.

K033392IMMEDIATE STABILIZING IMPLANT (ISI)K023336OCO DENTAL IMPLANT (5.0MM DIAMETER)K021460OCO DENTAL IMPLANTK011524IMMEDIATE STABILIZING DEVICE (ISD)K010142OCO DENTAL IMPLANTK973926O BUTMENT HS IMPLANT

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Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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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