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FDA 510(k)

O-RING PROSTHETIC ATTACHMENT DEVICE

K-Number: K900545 · 1990-06-22

ApplicantCalcitek, Inc.
Decision Date1990-06-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

O-RING PROSTHETIC ATTACHMENT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Calcitek, Inc.. It received FDA 510(k) clearance on 1990-06-22 under 510(k) number K900545. 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-RING PROSTHETIC ATTACHMENT DEVICE?

O-RING PROSTHETIC ATTACHMENT DEVICE is a medical device that received FDA 510(k) clearance on 1990-06-22. The listed applicant is Calcitek, Inc.. The 510(k) number is K900545.

When did O-RING PROSTHETIC ATTACHMENT DEVICE receive FDA 510(k) clearance?

O-RING PROSTHETIC ATTACHMENT DEVICE received FDA 510(k) clearance on 1990-06-22, under 510(k) number K900545.

Who is the listed applicant for O-RING PROSTHETIC ATTACHMENT DEVICE?

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

What is the FDA product code for O-RING PROSTHETIC ATTACHMENT DEVICE?

The FDA product code for O-RING PROSTHETIC ATTACHMENT DEVICE is DZE.

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Other records listing Calcitek, 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.

K962576SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEMK962106SPLINE DENTAL IMPLANT SYSTEMSK9556195.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMSK960021CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMSK943604INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEMK946319INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM

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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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