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FDA 510(k)

PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT

K-Number: K012794 · 2001-11-05

ApplicantPrime Dental Manufacturing, Inc.
Decision Date2001-11-05
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRIME-DENT CHEMICAL 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 2001-11-05 under 510(k) number K012794. 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 PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT?

PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT is a medical device that received FDA 510(k) clearance on 2001-11-05. The listed applicant is Prime Dental Manufacturing, Inc.. The 510(k) number is K012794.

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

PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT received FDA 510(k) clearance on 2001-11-05, under 510(k) number K012794.

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

The FDA product code for PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT is EBF.

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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 DESENSITIZERK012761PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANTK012673PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM

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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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