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FDA 510(k)

SUPER SEAL

K-Number: K983477 · 1998-12-22

ApplicantPhoenix Dental, Inc.
Decision Date1998-12-22
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUPER SEAL is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Dental, Inc.. It received FDA 510(k) clearance on 1998-12-22 under 510(k) number K983477. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPER SEAL?

SUPER SEAL is a medical device that received FDA 510(k) clearance on 1998-12-22. The listed applicant is Phoenix Dental, Inc.. The 510(k) number is K983477.

When did SUPER SEAL receive FDA 510(k) clearance?

SUPER SEAL received FDA 510(k) clearance on 1998-12-22, under 510(k) number K983477.

Who is the listed applicant for SUPER SEAL?

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

What is the FDA product code for SUPER SEAL?

The FDA product code for SUPER SEAL is EJK.

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Other records listing Phoenix Dental, 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.

K120109SUPER SEAL TOOTH DESENSITIZERK102821DISCOVREDK926101PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDROK926102PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN

Related Devices (Code: EJK)

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.

K261728One-Fil LCMediclus Co., Ltd.K253248Bright Cavity LinerDmp Dental Industry S.A.K2302703M™ VitCal Liner/Base3M Espe Dental ProductsK212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro LimitedK201799CleaniCalMaruchiK202413LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten GmbH

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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