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FDA 510(k)

UNIREST COMPOSITE RESTORATIVE, SELF CURED

K-Number: K884350 · 1989-01-03

ApplicantScientific Pharmaceuticals, Inc.
Decision Date1989-01-03
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UNIREST COMPOSITE RESTORATIVE, SELF CURED 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 1989-01-03 under 510(k) number K884350. 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 UNIREST COMPOSITE RESTORATIVE, SELF CURED?

UNIREST COMPOSITE RESTORATIVE, SELF CURED is a medical device that received FDA 510(k) clearance on 1989-01-03. The listed applicant is Scientific Pharmaceuticals, Inc.. The 510(k) number is K884350.

When did UNIREST COMPOSITE RESTORATIVE, SELF CURED receive FDA 510(k) clearance?

UNIREST COMPOSITE RESTORATIVE, SELF CURED received FDA 510(k) clearance on 1989-01-03, under 510(k) number K884350.

Who is the listed applicant for UNIREST COMPOSITE RESTORATIVE, SELF CURED?

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 UNIREST COMPOSITE RESTORATIVE, SELF CURED?

The FDA product code for UNIREST COMPOSITE RESTORATIVE, SELF CURED 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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