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FDA 510(k)

SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM

K-Number: K962576 · 1997-02-10

ApplicantCalcitek, Inc.
Decision Date1997-02-10
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Calcitek, Inc.. It received FDA 510(k) clearance on 1997-02-10 under 510(k) number K962576. 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 SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM?

SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-02-10. The listed applicant is Calcitek, Inc.. The 510(k) number is K962576.

When did SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM receive FDA 510(k) clearance?

SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM received FDA 510(k) clearance on 1997-02-10, under 510(k) number K962576.

Who is the listed applicant for SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM?

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 SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM?

The FDA product code for SPLINE X ENDOSSEOUS DENTAL IMPLANT SYSTEM 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.

K962106SPLINE DENTAL IMPLANT SYSTEMSK9556195.0MM SPLINE ENDOSSEOUS DENTAL IMPLANT SYSTEMSK943604INTEGRAL V BIOINTEGRATED DENTAL IMPLANT SYSTEMK960021CALCITEK HA-COATED ENDOSSEOUS DENTAL IMPLANT SYSTEMSK946345INTEGRAL VIII BIOINTEGRATED DENTAL IMPLANT SYSTEMK946319INTEGRAL VII 4.9MM BIOINTEGRATED DENTAL IMPLANT SYSTEM

View all 21 devices →

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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