Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

IDEAL 1 ORTHODONTIC BRACKET ADHESIVE

K-Number: K033703 · 2004-02-06

ApplicantDentsply Intl.
Decision Date2004-02-06
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IDEAL 1 ORTHODONTIC BRACKET ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 2004-02-06 under 510(k) number K033703. 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 IDEAL 1 ORTHODONTIC BRACKET ADHESIVE?

IDEAL 1 ORTHODONTIC BRACKET ADHESIVE is a medical device that received FDA 510(k) clearance on 2004-02-06. The listed applicant is Dentsply Intl.. The 510(k) number is K033703.

When did IDEAL 1 ORTHODONTIC BRACKET ADHESIVE receive FDA 510(k) clearance?

IDEAL 1 ORTHODONTIC BRACKET ADHESIVE received FDA 510(k) clearance on 2004-02-06, under 510(k) number K033703.

Who is the listed applicant for IDEAL 1 ORTHODONTIC BRACKET ADHESIVE?

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

What is the FDA product code for IDEAL 1 ORTHODONTIC BRACKET ADHESIVE?

The FDA product code for IDEAL 1 ORTHODONTIC BRACKET ADHESIVE is DYH.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dentsply Intl. 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.

K123615IRIS - HIGH STRENGTH GLASS CERAMICK072730FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTSK070538XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVEK070019CARRARA VOLUMIAK061427PRE-IMPRESSION CONDITIONING SOLUTIONK052334CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131

View all 279 devices →

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.

↑