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FDA 510(k)

EDOSSEOUS DENTAL IMPLANT

K-Number: K970127 · 1997-06-23

ApplicantSulzer Calcitek, Inc.
Decision Date1997-06-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EDOSSEOUS DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Sulzer Calcitek, Inc.. It received FDA 510(k) clearance on 1997-06-23 under 510(k) number K970127. 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 EDOSSEOUS DENTAL IMPLANT?

EDOSSEOUS DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 1997-06-23. The listed applicant is Sulzer Calcitek, Inc.. The 510(k) number is K970127.

When did EDOSSEOUS DENTAL IMPLANT receive FDA 510(k) clearance?

EDOSSEOUS DENTAL IMPLANT received FDA 510(k) clearance on 1997-06-23, under 510(k) number K970127.

Who is the listed applicant for EDOSSEOUS DENTAL IMPLANT?

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

What is the FDA product code for EDOSSEOUS DENTAL IMPLANT?

The FDA product code for EDOSSEOUS DENTAL IMPLANT is DZE.

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Other records listing Sulzer 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.

K010073SPLINE DENTAL IMPLANT SYSTEMK001786TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOGK984536REMOVABLE CUFF ABUTMENTK982305SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENTK981562SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANTK973521VARIABLE PARALLEL PIN

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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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