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)

RUBBER DAM HOLDER

K-Number: K781520 · 1978-10-10

ApplicantYoung Dental Manufacturing Co. 1, LLC
Decision Date1978-10-10
Product CodeEJE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RUBBER DAM HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Young Dental Manufacturing Co. 1, LLC. It received FDA 510(k) clearance on 1978-10-10 under 510(k) number K781520. The device is classified under product code EJE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBBER DAM HOLDER?

RUBBER DAM HOLDER is a medical device that received FDA 510(k) clearance on 1978-10-10. The listed applicant is Young Dental Manufacturing Co. 1, LLC. The 510(k) number is K781520.

When did RUBBER DAM HOLDER receive FDA 510(k) clearance?

RUBBER DAM HOLDER received FDA 510(k) clearance on 1978-10-10, under 510(k) number K781520.

Who is the listed applicant for RUBBER DAM HOLDER?

The FDA 510(k) record lists Young Dental Manufacturing Co. 1, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RUBBER DAM HOLDER?

The FDA product code for RUBBER DAM HOLDER is EJE.

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 Young Dental Manufacturing Co. 1, LLC 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.

K241041Silver Fluoride Hypersensitivity VarnishK201127DEFEND Ear-loop Face MasksK171377Young INFINITY Cordless Handpiece SystemK153334Oral-B 5% Sodium Fluoride VarnishK932255YOUNG D'GRANULATORK903284YOUNG PROPHY SYSTEM, PS UNIT

View all 16 devices →

Related Devices (Code: EJE)

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.

K780746HYGIENIC RUBBER DAM FRAMEHygienic Dental Mfg., Co., TheK770117HYGIENIC 5 & 6 RUBBER DAM FRAMEHygienic Dental Mfg., Co., The

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.

↑