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)

ADP FACEMASK

K-Number: K923556 · 1992-12-04

ApplicantOrmco Corp.
Decision Date1992-12-04
Product CodeDZB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADP FACEMASK is the device name listed in this FDA 510(k) record. The listed applicant is Ormco Corp.. It received FDA 510(k) clearance on 1992-12-04 under 510(k) number K923556. The device is classified under product code DZB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADP FACEMASK?

ADP FACEMASK is a medical device that received FDA 510(k) clearance on 1992-12-04. The listed applicant is Ormco Corp.. The 510(k) number is K923556.

When did ADP FACEMASK receive FDA 510(k) clearance?

ADP FACEMASK received FDA 510(k) clearance on 1992-12-04, under 510(k) number K923556.

Who is the listed applicant for ADP FACEMASK?

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

What is the FDA product code for ADP FACEMASK?

The FDA product code for ADP FACEMASK is DZB.

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 Ormco Corp. 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.

K123118INSIGNIA DIGICASTK123416INSIGNIA WITH ITEROK122065DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USEK121524INSIGNIAK112640HYPERELASTIC WIREK101676CLEARARCH

View all 39 devices →

Related Devices (Code: DZB)

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.

K202855Orthodontic FacemaskIta.O Italian Orthodontic System S.R.L.K162543Reverse Pull Adjustable FacemaskSawbros Industries Pvt., Ltd.K111169PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMFKwang Myung Daicom, Inc.K103019KJ MASKKj Meditech Co., Ltd.K052553NITOM LOCKING FACEBOWRussell Samuels Orthodontic DesignK051751EQUA-PULL SAFETY RELEASE MODULEOrtho Technology

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.

↑