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FDA 510(k)

SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL

K-Number: K972935 · 1998-01-29

ApplicantS.S. White Mfg., Ltd.
Decision Date1998-01-29
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is S.S. White Mfg., Ltd.. It received FDA 510(k) clearance on 1998-01-29 under 510(k) number K972935. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL?

SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL is a medical device that received FDA 510(k) clearance on 1998-01-29. The listed applicant is S.S. White Mfg., Ltd.. The 510(k) number is K972935.

When did SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL receive FDA 510(k) clearance?

SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL received FDA 510(k) clearance on 1998-01-29, under 510(k) number K972935.

Who is the listed applicant for SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL?

The FDA 510(k) record lists S.S. White Mfg., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL?

The FDA product code for SUPER-DENT INTERMEDIATE RESTORATIVE MATERIAL is EMA.

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Other records listing S.S. White Mfg., Ltd. 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.

K965083SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SETK964179SUPER-DENT ETCHING GEL, SUPER-DENT MICRO-ETCH GEL AND SUPER-DENT ETCHING GEL SYRINGE TIPS

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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