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FDA 510(k)

DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE

K-Number: K030977 · 2003-08-25

ApplicantDentaurum
Decision Date2003-08-25
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Dentaurum. It received FDA 510(k) clearance on 2003-08-25 under 510(k) number K030977. 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 DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE?

DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE is a medical device that received FDA 510(k) clearance on 2003-08-25. The listed applicant is Dentaurum. The 510(k) number is K030977.

When did DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE receive FDA 510(k) clearance?

DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE received FDA 510(k) clearance on 2003-08-25, under 510(k) number K030977.

Who is the listed applicant for DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE?

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

What is the FDA product code for DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE?

The FDA product code for DENTAURUM MIX TWO-PASTE BRACKET ADHESIVE is DYH.

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Other records listing Dentaurum 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.

K062733TOMAS PIN SD 6, 8, AND 10 MMK062732TOMAS PIN 6 MMK030644CONTEC DUO, CONTEC LC, CONTEC LCRK032195DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENTK030980DENTAURUM NO-MIX ONE STEP BRACKET ADHESIVEK030641CONTEC LIGHT

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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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