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)

ULTRADENT CITRIC ACID 10% SOLUTION

K-Number: K032627 · 2003-11-12

ApplicantUltradent Products, Inc.
Decision Date2003-11-12
Product CodeKJJ
DecisionSubstantially Equivalent

Device Summary

ULTRADENT CITRIC ACID 10% SOLUTION is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2003-11-12 under 510(k) number K032627. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRADENT CITRIC ACID 10% SOLUTION?

ULTRADENT CITRIC ACID 10% SOLUTION is a medical device that received FDA 510(k) clearance on 2003-11-12. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K032627.

When did ULTRADENT CITRIC ACID 10% SOLUTION receive FDA 510(k) clearance?

ULTRADENT CITRIC ACID 10% SOLUTION received FDA 510(k) clearance on 2003-11-12, under 510(k) number K032627.

Who is the listed applicant for ULTRADENT CITRIC ACID 10% SOLUTION?

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

What is the FDA product code for ULTRADENT CITRIC ACID 10% SOLUTION?

The FDA product code for ULTRADENT CITRIC ACID 10% SOLUTION is KJJ.

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 Ultradent Products, 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.

K262228Transcend Bulk Fill Flowable CompositeK261404UltraEZK240743Peak Universal BondK240694FORMA Composite (Shade A3D)K221909J-TempK220471VALO X, VALO X Accessory Lenses

View all 102 devices →

Related Devices (Code: KJJ)

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.

K250279RC-SwiftPrepBelport Company, Inc., Gingi-PakK241354Sealer SolventInter-Med, Inc.K201785EPIEN Dental CleanserEpien Medical, Inc.K211813TritonInter-Med / Vista DentalK193357V-MixInter-Med/Vista Dental ProductsK193409Vista Rinse, Vista Rinse PlusInter-Med/Vista Dental Products

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.

↑