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FDA 510(k)

VERSA-LINK PORCELAIN BONDING SYSTEM

K-Number: K052699 · 2005-11-16

ApplicantSultan Chemists, Inc.
Decision Date2005-11-16
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VERSA-LINK PORCELAIN BONDING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sultan Chemists, Inc.. It received FDA 510(k) clearance on 2005-11-16 under 510(k) number K052699. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSA-LINK PORCELAIN BONDING SYSTEM?

VERSA-LINK PORCELAIN BONDING SYSTEM is a medical device that received FDA 510(k) clearance on 2005-11-16. The listed applicant is Sultan Chemists, Inc.. The 510(k) number is K052699.

When did VERSA-LINK PORCELAIN BONDING SYSTEM receive FDA 510(k) clearance?

VERSA-LINK PORCELAIN BONDING SYSTEM received FDA 510(k) clearance on 2005-11-16, under 510(k) number K052699.

Who is the listed applicant for VERSA-LINK PORCELAIN BONDING SYSTEM?

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

What is the FDA product code for VERSA-LINK PORCELAIN BONDING SYSTEM?

The FDA product code for VERSA-LINK PORCELAIN BONDING SYSTEM is KLE.

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Other records listing Sultan Chemists, 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.

K052409SILGIMIX ALGINATE REPLACEMENT IMPRESSION MATERIALK043054GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIALK030414GENIE ULTRA HYDROPHILIC IMPRESSION MATERIALK020612SULTAN SPOROX TEST VIAL, MODEL 75195K002843SULTAN SENSITEMP RESIN TEMPORARY CEMENT, MODEL 70010K991509PRO-PORTION CLEANER/DISINFECTANT

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Related Devices (Code: KLE)

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.

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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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