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)

PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER

K-Number: K033675 · 2004-01-15

ApplicantSirona Dental Systems GmbH
Decision Date2004-01-15
Product CodeKOJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER is the device name listed in this FDA 510(k) record. The listed applicant is Sirona Dental Systems GmbH. It received FDA 510(k) clearance on 2004-01-15 under 510(k) number K033675. The device is classified under product code KOJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER?

PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER is a medical device that received FDA 510(k) clearance on 2004-01-15. The listed applicant is Sirona Dental Systems GmbH. The 510(k) number is K033675.

When did PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER receive FDA 510(k) clearance?

PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER received FDA 510(k) clearance on 2004-01-15, under 510(k) number K033675.

Who is the listed applicant for PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER?

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

What is the FDA product code for PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER?

The FDA product code for PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER is KOJ.

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 Sirona Dental Systems GmbH 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.

K160099CEREC SpeedGlazeK132773SIDEXIS 4K123664INCORIS ZIK123952CEREC BLOCS C INK123070GALILEOS FAMILYK123545INCORIS TZI

View all 37 devices →

Related Devices (Code: KOJ)

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.

K251425turbodent touchMectron S.P.A.K063236BETA-POWDERBrainbase CorporationK042872RONDOFLEX PLUS 360Kavo America CorporationK033215PREPAIRDanville Materials, Inc.K024105VELOPEX AQUACUT FLUID ABRASION UNITVelopex International, Inc.K030292GROMAN PREPMASTERGroman, Inc.

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.

↑