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FDA 510(k)

COMPOSITE DENTAL RESTORATIVE MATERIAL

K-Number: K813090 · 1981-11-24

ApplicantSci-Pharm, Inc.
Decision Date1981-11-24
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COMPOSITE DENTAL RESTORATIVE MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Sci-Pharm, Inc.. It received FDA 510(k) clearance on 1981-11-24 under 510(k) number K813090. 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 COMPOSITE DENTAL RESTORATIVE MATERIAL?

COMPOSITE DENTAL RESTORATIVE MATERIAL is a medical device that received FDA 510(k) clearance on 1981-11-24. The listed applicant is Sci-Pharm, Inc.. The 510(k) number is K813090.

When did COMPOSITE DENTAL RESTORATIVE MATERIAL receive FDA 510(k) clearance?

COMPOSITE DENTAL RESTORATIVE MATERIAL received FDA 510(k) clearance on 1981-11-24, under 510(k) number K813090.

Who is the listed applicant for COMPOSITE DENTAL RESTORATIVE MATERIAL?

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

What is the FDA product code for COMPOSITE DENTAL RESTORATIVE MATERIAL?

The FDA product code for COMPOSITE DENTAL RESTORATIVE MATERIAL is EBF.

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Other records listing Sci-Pharm, 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.

K823935MICRO JOIN, CROWN & BRIDGE ADHESIVEK820092SECURE-ON-TOUCHK813091FISSURE SEALER & BONDING AGENTK812546BEAUDENTK812545BEAUFILLK812550BEAUCAV

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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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