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FDA 510(k)

CEMENT, DENTAL/CAVITY LINER

K-Number: K781281 · 1978-08-21

ApplicantStar Dental Mfg. Co.
Decision Date1978-08-21
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CEMENT, DENTAL/CAVITY LINER is the device name listed in this FDA 510(k) record. The listed applicant is Star Dental Mfg. Co.. It received FDA 510(k) clearance on 1978-08-21 under 510(k) number K781281. 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 CEMENT, DENTAL/CAVITY LINER?

CEMENT, DENTAL/CAVITY LINER is a medical device that received FDA 510(k) clearance on 1978-08-21. The listed applicant is Star Dental Mfg. Co.. The 510(k) number is K781281.

When did CEMENT, DENTAL/CAVITY LINER receive FDA 510(k) clearance?

CEMENT, DENTAL/CAVITY LINER received FDA 510(k) clearance on 1978-08-21, under 510(k) number K781281.

Who is the listed applicant for CEMENT, DENTAL/CAVITY LINER?

The FDA 510(k) record lists Star Dental Mfg. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CEMENT, DENTAL/CAVITY LINER?

The FDA product code for CEMENT, DENTAL/CAVITY LINER is EMA.

Related Clinical Trials

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Other records listing Star Dental Mfg. Co. 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.

K905155HIGH SPEED CEREAMIC BEARING TURBINE HANDPIECESK782007ROTARY SCALERK771247CORE MATERIALK771246ALARM SYS FOR NITROUS OXIDE SYS.

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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