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)

PULPDENT ETCH-RITE ROYALE

K-Number: K031915 · 2003-08-05

ApplicantPulpdent Corporation
Decision Date2003-08-05
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PULPDENT ETCH-RITE ROYALE is the device name listed in this FDA 510(k) record. The listed applicant is Pulpdent Corporation. It received FDA 510(k) clearance on 2003-08-05 under 510(k) number K031915. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULPDENT ETCH-RITE ROYALE?

PULPDENT ETCH-RITE ROYALE is a medical device that received FDA 510(k) clearance on 2003-08-05. The listed applicant is Pulpdent Corporation. The 510(k) number is K031915.

When did PULPDENT ETCH-RITE ROYALE receive FDA 510(k) clearance?

PULPDENT ETCH-RITE ROYALE received FDA 510(k) clearance on 2003-08-05, under 510(k) number K031915.

Who is the listed applicant for PULPDENT ETCH-RITE ROYALE?

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

What is the FDA product code for PULPDENT ETCH-RITE ROYALE?

The FDA product code for PULPDENT ETCH-RITE ROYALE is KLE.

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 Pulpdent Corporation 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.

K210045ACTIVA PRESTO PACKK173020OBA-MCP, Orthodontic Bracket Adhesive with MCPK172169Pulpdent (Activa) Pit and Fissure Sealant with MCPK153249Pulpdent Solo Flowable Composite with MCPK130223RMGI FILLK123265RMGI LOW VISCOSITY

View all 32 devices →

Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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.

↑