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FDA 510(k)

CORE MATERIAL

K-Number: K771247 · 1977-07-15

ApplicantStar Dental Mfg. Co.
Decision Date1977-07-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CORE MATERIAL 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 1977-07-15 under 510(k) number K771247. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORE MATERIAL?

CORE MATERIAL is a medical device that received FDA 510(k) clearance on 1977-07-15. The listed applicant is Star Dental Mfg. Co.. The 510(k) number is K771247.

When did CORE MATERIAL receive FDA 510(k) clearance?

CORE MATERIAL received FDA 510(k) clearance on 1977-07-15, under 510(k) number K771247.

Who is the listed applicant for CORE MATERIAL?

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 CORE MATERIAL?

The FDA product code for CORE MATERIAL is EBF.

Related Clinical Trials

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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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 SCALERK781281CEMENT, DENTAL/CAVITY LINERK771246ALARM SYS FOR NITROUS OXIDE SYS.

Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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