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FDA 510(k)

PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM

K-Number: K012673 · 2001-10-24

ApplicantPrime Dental Manufacturing, Inc.
Decision Date2001-10-24
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM 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 2001-10-24 under 510(k) number K012673. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM?

PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM is a medical device that received FDA 510(k) clearance on 2001-10-24. The listed applicant is Prime Dental Manufacturing, Inc.. The 510(k) number is K012673.

When did PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM receive FDA 510(k) clearance?

PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM received FDA 510(k) clearance on 2001-10-24, under 510(k) number K012673.

Who is the listed applicant for PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM?

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 ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM?

The FDA product code for PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM is DYH.

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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 SEALANTK012761PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT

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Related Devices (Code: DYH)

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.

K261129OrthoFitSpident Co., Ltd.K261840BracePaste Prime PlusAmerican OrthodonticsK250015Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree AdhesiveOrmco CorporationK242537BracePaste Fluoride SealantAmerican Orthodontics Corp.K2340433M™ Transbond™ Orthodontic Adhesive3M Unitek Orthodontic ProductsK231817AlignerFlow LCVoco GmbH

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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