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FDA 510(k)

LIGHT CURE DENTAL DAM

K-Number: K021524 · 2002-07-19

ApplicantPrime Dental Manufacturing, Inc.
Decision Date2002-07-19
Product CodeEIE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LIGHT CURE DENTAL DAM 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 2002-07-19 under 510(k) number K021524. The device is classified under product code EIE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHT CURE DENTAL DAM?

LIGHT CURE DENTAL DAM is a medical device that received FDA 510(k) clearance on 2002-07-19. The listed applicant is Prime Dental Manufacturing, Inc.. The 510(k) number is K021524.

When did LIGHT CURE DENTAL DAM receive FDA 510(k) clearance?

LIGHT CURE DENTAL DAM received FDA 510(k) clearance on 2002-07-19, under 510(k) number K021524.

Who is the listed applicant for LIGHT CURE DENTAL DAM?

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 LIGHT CURE DENTAL DAM?

The FDA product code for LIGHT CURE DENTAL DAM is EIE.

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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 MATERIALK013970PRIME-DENT HEMA DESENSITIZERK012794PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANTK012761PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANTK012673PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM

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Related Devices (Code: EIE)

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.

K182118armor LCMavrik Dental Systems, Ltd.K151945Triumph Resin DamDenali CorporationK050318BARI-KAD PACKING DEVICEBioenvelop Agro, Inc.K043301GC TION GINGIVAL PROTECTORGC America, Inc.K040797BRITESMILE MASKING CREAMBritesmile, Inc.K022522PULPDENT PUTTY DAMPulpdent Corporation

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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