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FDA 510(k)

SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT

K-Number: K981562 · 1998-07-30

ApplicantSulzer Calcitek, Inc.
Decision Date1998-07-30
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI 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 1998-07-30 under 510(k) number K981562. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT?

SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT is a medical device that received FDA 510(k) clearance on 1998-07-30. The listed applicant is Sulzer Calcitek, Inc.. The 510(k) number is K981562.

When did SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT receive FDA 510(k) clearance?

SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT received FDA 510(k) clearance on 1998-07-30, under 510(k) number K981562.

Who is the listed applicant for SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI 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 SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT?

The FDA product code for SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT is EBF.

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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 ABUTMENTK973521VARIABLE PARALLEL PINK970752SPLINE ENGAGING SHOULDERED ABUTMENT SYSTEM

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Related Devices (Code: EBF)

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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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