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)

AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS)

K-Number: K964772 · 1997-01-17

ApplicantIvoclar North America, Inc.
Decision Date1997-01-17
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS) is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar North America, Inc.. It received FDA 510(k) clearance on 1997-01-17 under 510(k) number K964772. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS)?

AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS) is a medical device that received FDA 510(k) clearance on 1997-01-17. The listed applicant is Ivoclar North America, Inc.. The 510(k) number is K964772.

When did AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS) receive FDA 510(k) clearance?

AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS) received FDA 510(k) clearance on 1997-01-17, under 510(k) number K964772.

Who is the listed applicant for AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS)?

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

What is the FDA product code for AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS)?

The FDA product code for AQUARIUS HPF (WILL BE SOLD AS WILLIAMS CLASSIC VISIONS) is EJT.

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 Ivoclar North America, 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.

K012174ERIS LAYERING MATERIALSK011491HELIOSEAL CLEAR CHROMAK011492IN TEN-SK011490MODIFICATION TO EXCITEK011023D.SIGN 96K011022BIOUNIVERSAL PDF

View all 131 devices →

Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,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.

↑