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FDA 510(k)

PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT

K-Number: K854882 · 1986-01-30

ApplicantLee Pharmaceuticals
Decision Date1986-01-30
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT is the device name listed in this FDA 510(k) record. The listed applicant is Lee Pharmaceuticals. It received FDA 510(k) clearance on 1986-01-30 under 510(k) number K854882. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT?

PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT is a medical device that received FDA 510(k) clearance on 1986-01-30. The listed applicant is Lee Pharmaceuticals. The 510(k) number is K854882.

When did PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT receive FDA 510(k) clearance?

PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT received FDA 510(k) clearance on 1986-01-30, under 510(k) number K854882.

Who is the listed applicant for PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT?

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

What is the FDA product code for PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT?

The FDA product code for PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT is EBC.

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Other records listing Lee Pharmaceuticals 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.

K924378RESTOBOND 4K912256PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERTK900809LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETSK894315RESTOBOND 3/DENTIN-ENAMEL BONDING AGENTK881903PROSTHODENT VLK873123LEE COMPOSITE INLAY SYSTEM

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Related Devices (Code: EBC)

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.

K260819Any-Com SealMediclus Co., Ltd.K243254Parkell Pit and Fissure SealantParkell, Inc.K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.K230455Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd.K190998BA Pit & Fissure SealantApex Dental Materials, Inc.K190339Helioseal F PlusIvoclar Vivadent, AG

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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