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)

SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE

K-Number: K023232 · 2002-12-11

ApplicantSmartpractice
Decision Date2002-12-11
Product CodeEFS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE is the device name listed in this FDA 510(k) record. The listed applicant is Smartpractice. It received FDA 510(k) clearance on 2002-12-11 under 510(k) number K023232. The device is classified under product code EFS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE?

SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE is a medical device that received FDA 510(k) clearance on 2002-12-11. The listed applicant is Smartpractice. The 510(k) number is K023232.

When did SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE receive FDA 510(k) clearance?

SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE received FDA 510(k) clearance on 2002-12-11, under 510(k) number K023232.

Who is the listed applicant for SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE?

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

What is the FDA product code for SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE?

The FDA product code for SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLE is EFS.

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 Smartpractice 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.

K123184FINN CHAMBERS AQUAK103409ALLERGEAZE R CLEARK063160ALLERGEAZE PATCH TEST CHAMBERS

Related Devices (Code: EFS)

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.

K001493DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001Air Force, Inc.K983374AGATHA-A-H2010Midian Intl.K964810DERMADAMUltradent Products, Inc.K952234BARRIER ALL FILMCottrell, Ltd.K943182ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOROral-B LaboratoriesK923711PERIOFLEX TIPNovadent, Ltd.

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.

↑