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FDA 510(k)

ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT

K-Number: K945300 · 1995-02-16

ApplicantO Co., Inc.
Decision Date1995-02-16
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT 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 1995-02-16 under 510(k) number K945300. 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 ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT?

ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1995-02-16. The listed applicant is O Co., Inc.. The 510(k) number is K945300.

When did ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT receive FDA 510(k) clearance?

ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT received FDA 510(k) clearance on 1995-02-16, under 510(k) number K945300.

Who is the listed applicant for ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT?

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 ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT?

The FDA product code for ACCESSORY ITEM TO ENDOSSEOUS DENTAL IMPLANT 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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