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)

O-TRAY IMPRESSION TRAYS

K-Number: K942668 · 1994-07-22

ApplicantDentauraum, Inc.
Decision Date1994-07-22
Product CodeEHY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

O-TRAY IMPRESSION TRAYS is the device name listed in this FDA 510(k) record. The listed applicant is Dentauraum, Inc.. It received FDA 510(k) clearance on 1994-07-22 under 510(k) number K942668. The device is classified under product code EHY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the O-TRAY IMPRESSION TRAYS?

O-TRAY IMPRESSION TRAYS is a medical device that received FDA 510(k) clearance on 1994-07-22. The listed applicant is Dentauraum, Inc.. The 510(k) number is K942668.

When did O-TRAY IMPRESSION TRAYS receive FDA 510(k) clearance?

O-TRAY IMPRESSION TRAYS received FDA 510(k) clearance on 1994-07-22, under 510(k) number K942668.

Who is the listed applicant for O-TRAY IMPRESSION TRAYS?

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

What is the FDA product code for O-TRAY IMPRESSION TRAYS?

The FDA product code for O-TRAY IMPRESSION TRAYS is EHY.

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 Dentauraum, 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.

K952867REMANIUM:GM 700, GM 380, GM 800, GFHK952866REMATITAN TITANIUMK952870REMANIUM: CS & G-SOFTK952865REMANIUM: 200,CS, 380, AND CDK952868DENTAURUM JACKET CROWN & ROOT POSTSK942667DENT-O-CRYL ORTHODONTIC ACRYLIC

View all 24 devices →

Related Devices (Code: EHY)

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.

K896470EOS IMPRESSION TRAYSIvoclar North America, Inc.K884316OCCLUSAL HARMONY IMPRESSION TRAYAdvantage Dental Co.K863836POST TRAYMarket Masters, Inc.K850776PREFORMED DENTAL IMPRESSION TRAYSL.A.K. Ent., Inc.K842273CROWN INDEX TRAYDi-Equi Dental ProductsK842274F-G-P TRAYDi-Equi 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.

↑