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)

DENTRAY II PLUS TRAY ADHESIVE

K-Number: K952930 · 1995-09-08

ApplicantConfi-Dental Products Co.
Decision Date1995-09-08
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTRAY II PLUS TRAY ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Confi-Dental Products Co.. It received FDA 510(k) clearance on 1995-09-08 under 510(k) number K952930. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTRAY II PLUS TRAY ADHESIVE?

DENTRAY II PLUS TRAY ADHESIVE is a medical device that received FDA 510(k) clearance on 1995-09-08. The listed applicant is Confi-Dental Products Co.. The 510(k) number is K952930.

When did DENTRAY II PLUS TRAY ADHESIVE receive FDA 510(k) clearance?

DENTRAY II PLUS TRAY ADHESIVE received FDA 510(k) clearance on 1995-09-08, under 510(k) number K952930.

Who is the listed applicant for DENTRAY II PLUS TRAY ADHESIVE?

The FDA 510(k) record lists Confi-Dental Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTRAY II PLUS TRAY ADHESIVE?

The FDA product code for DENTRAY II PLUS TRAY ADHESIVE is ELW.

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 Confi-Dental Products Co. 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.

K030807CARIES INDICATORK030743ETCHANT 40%K955329RESILIENCE M5 PROTECTION PLUSK955328CONFI-BONDK954988CRYSTALLESSENCEK946307CYRSTALLINE L3 MULTI-USE HYBRID COMPOSITE

View all 31 devices →

Related Devices (Code: ELW)

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.

K254152Dia-X Sil Light BodyDiaDent Group InternationalK254142Dia-X Sil Heavy BodyDiaDent Group InternationalK254112Dia-X Sil BiteDiaDent Group InternationalK253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);Vigodent Indústria E Comercio LtdaK250969JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFASTDent4you AGK241924Elastic Impression MaterialBeijing Okvd Biological Technology , 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.

↑