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FDA 510(k)

PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT

K-Number: K012761 · 2001-11-01

ApplicantPrime Dental Manufacturing, Inc.
Decision Date2001-11-01
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT is the device name listed in this FDA 510(k) record. The listed applicant is Prime Dental Manufacturing, Inc.. It received FDA 510(k) clearance on 2001-11-01 under 510(k) number K012761. 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 PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT?

PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT is a medical device that received FDA 510(k) clearance on 2001-11-01. The listed applicant is Prime Dental Manufacturing, Inc.. The 510(k) number is K012761.

When did PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT receive FDA 510(k) clearance?

PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT received FDA 510(k) clearance on 2001-11-01, under 510(k) number K012761.

Who is the listed applicant for PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT?

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

What is the FDA product code for PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT?

The FDA product code for PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT is EBC.

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Other records listing Prime Dental Manufacturing, 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.

K112574PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENTK022675PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIALK021524LIGHT CURE DENTAL DAMK013970PRIME-DENT HEMA DESENSITIZERK012794PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANTK012673PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING 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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