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FDA 510(k)

INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING

K-Number: K941608 · 1995-05-05

ApplicantCalcitek, Inc.
Decision Date1995-05-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING is the device name listed in this FDA 510(k) record. The listed applicant is Calcitek, Inc.. It received FDA 510(k) clearance on 1995-05-05 under 510(k) number K941608. 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 INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING?

INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING is a medical device that received FDA 510(k) clearance on 1995-05-05. The listed applicant is Calcitek, Inc.. The 510(k) number is K941608.

When did INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING receive FDA 510(k) clearance?

INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING received FDA 510(k) clearance on 1995-05-05, under 510(k) number K941608.

Who is the listed applicant for INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING?

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 INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING?

The FDA product code for INTEGRAL OMNILOC DENTAL IMPLANT WITH INTERFACE RING 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 SYSTEMK946345INTEGRAL VIII 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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