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)

REMOLDABLE CRANIOMANDIBULAR APPLIANCE

K-Number: K833455 · 1984-01-10

ApplicantJeffrey H. Attlin
Decision Date1984-01-10
Product CodeKMY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REMOLDABLE CRANIOMANDIBULAR APPLIANCE is the device name listed in this FDA 510(k) record. The listed applicant is Jeffrey H. Attlin. It received FDA 510(k) clearance on 1984-01-10 under 510(k) number K833455. The device is classified under product code KMY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REMOLDABLE CRANIOMANDIBULAR APPLIANCE?

REMOLDABLE CRANIOMANDIBULAR APPLIANCE is a medical device that received FDA 510(k) clearance on 1984-01-10. The listed applicant is Jeffrey H. Attlin. The 510(k) number is K833455.

When did REMOLDABLE CRANIOMANDIBULAR APPLIANCE receive FDA 510(k) clearance?

REMOLDABLE CRANIOMANDIBULAR APPLIANCE received FDA 510(k) clearance on 1984-01-10, under 510(k) number K833455.

Who is the listed applicant for REMOLDABLE CRANIOMANDIBULAR APPLIANCE?

The FDA 510(k) record lists Jeffrey H. Attlin as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REMOLDABLE CRANIOMANDIBULAR APPLIANCE?

The FDA product code for REMOLDABLE CRANIOMANDIBULAR APPLIANCE is KMY.

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

Related Devices (Code: KMY)

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.

K931615NITE-GUIDEORTHO-TAIN, Inc.K942667DENT-O-CRYL ORTHODONTIC ACRYLICDentauraum, Inc.K924351GLENROE ELASTIBITE STIMULATORGlenroe TechnologiesK925064RELAX-O-GUARDAquatemp Service Co., Inc.K924975THE ORTHOTRAINERMyofunctional Research Corp. Pty. , Ltd.K924974THE TMJ APPLIANCEMyofunctional Research Corp. Pty. , 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.

↑