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FDA 510(k)

FLUOROSEAL, DENTIN SEALER AND CAVITY LINER

K-Number: K860633 · 1986-04-11

ApplicantScientific Pharmaceuticals, Inc.
Decision Date1986-04-11
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLUOROSEAL, DENTIN SEALER AND CAVITY LINER 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 1986-04-11 under 510(k) number K860633. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUOROSEAL, DENTIN SEALER AND CAVITY LINER?

FLUOROSEAL, DENTIN SEALER AND CAVITY LINER is a medical device that received FDA 510(k) clearance on 1986-04-11. The listed applicant is Scientific Pharmaceuticals, Inc.. The 510(k) number is K860633.

When did FLUOROSEAL, DENTIN SEALER AND CAVITY LINER receive FDA 510(k) clearance?

FLUOROSEAL, DENTIN SEALER AND CAVITY LINER received FDA 510(k) clearance on 1986-04-11, under 510(k) number K860633.

Who is the listed applicant for FLUOROSEAL, DENTIN SEALER AND CAVITY LINER?

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 FLUOROSEAL, DENTIN SEALER AND CAVITY LINER?

The FDA product code for FLUOROSEAL, DENTIN SEALER AND CAVITY LINER is LBH.

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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: LBH)

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.

K262243Profisil FreeKettenbach GmbH & Co. KGK253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd.K252073VOCO Profluorid Varnish + BioMinVoco GmbHK261404UltraEZUltradent Products, Inc.K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd.K250714FluoroDose VarnishCentrix, 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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