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FDA 510(k)

CALCITEK TORQUE WRENCH SYSTEM

K-Number: K931440 · 1994-01-26

ApplicantCalcitek, Inc.
Decision Date1994-01-26
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CALCITEK TORQUE WRENCH 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 1994-01-26 under 510(k) number K931440. 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 CALCITEK TORQUE WRENCH SYSTEM?

CALCITEK TORQUE WRENCH SYSTEM is a medical device that received FDA 510(k) clearance on 1994-01-26. The listed applicant is Calcitek, Inc.. The 510(k) number is K931440.

When did CALCITEK TORQUE WRENCH SYSTEM receive FDA 510(k) clearance?

CALCITEK TORQUE WRENCH SYSTEM received FDA 510(k) clearance on 1994-01-26, under 510(k) number K931440.

Who is the listed applicant for CALCITEK TORQUE WRENCH 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 CALCITEK TORQUE WRENCH SYSTEM?

The FDA product code for CALCITEK TORQUE WRENCH SYSTEM is DZE.

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Other records listing Calcitek, Inc. as applicant

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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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