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FDA 510(k)

SUMO GLASS IONOMER CEMENT

K-Number: K913519 · 1991-11-19

ApplicantOrtho Source
Decision Date1991-11-19
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUMO GLASS IONOMER CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Source. It received FDA 510(k) clearance on 1991-11-19 under 510(k) number K913519. 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 SUMO GLASS IONOMER CEMENT?

SUMO GLASS IONOMER CEMENT is a medical device that received FDA 510(k) clearance on 1991-11-19. The listed applicant is Ortho Source. The 510(k) number is K913519.

When did SUMO GLASS IONOMER CEMENT receive FDA 510(k) clearance?

SUMO GLASS IONOMER CEMENT received FDA 510(k) clearance on 1991-11-19, under 510(k) number K913519.

Who is the listed applicant for SUMO GLASS IONOMER CEMENT?

The FDA 510(k) record lists Ortho Source as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUMO GLASS IONOMER CEMENT?

The FDA product code for SUMO GLASS IONOMER CEMENT is EMA.

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Other records listing Ortho Source 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.

K913853FISSURE SEALERK913854ORTHO LIGHT CUREK884949VISIBLE LIGHT CURE CALCIUM HYDROXIDE LINERK884575MAXIBONDK861118ORTHOJOIN, ORTHODONTIC ADHESIVEK861258PERMABAND (ORTHODONTIC ADHESIVE)

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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

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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