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FDA 510(k)

ADR COMPOSITE RESTORATIVE

K-Number: K800439 · 1980-03-12

ApplicantScientific Pharmaceuticals, Inc.
Decision Date1980-03-12
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADR COMPOSITE RESTORATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1980-03-12 under 510(k) number K800439. 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 ADR COMPOSITE RESTORATIVE?

ADR COMPOSITE RESTORATIVE is a medical device that received FDA 510(k) clearance on 1980-03-12. The listed applicant is Scientific Pharmaceuticals, Inc.. The 510(k) number is K800439.

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

ADR COMPOSITE RESTORATIVE received FDA 510(k) clearance on 1980-03-12, under 510(k) number K800439.

Who is the listed applicant for ADR COMPOSITE RESTORATIVE?

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

What is the FDA product code for ADR COMPOSITE RESTORATIVE?

The FDA product code for ADR COMPOSITE RESTORATIVE is EBF.

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Other records listing Scientific Pharmaceuticals, 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.

K051952EUGENONEK041886PROVISOK013555SCI-PHARM POST SECUREK001446LIGHT-CURED ORTHODONTIC BAND CEMENTK993324CARBOCEM ZINC POLYCARBOXYLATE CEMENTK982915SCI-PHARM DFV VARNISH

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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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