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)

ORABRITE

K-Number: K780174 · 1978-02-23

ApplicantNorcliff Thayer, Inc.
Decision Date1978-02-23
Product CodeJER
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORABRITE is the device name listed in this FDA 510(k) record. The listed applicant is Norcliff Thayer, Inc.. It received FDA 510(k) clearance on 1978-02-23 under 510(k) number K780174. The device is classified under product code JER. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORABRITE?

ORABRITE is a medical device that received FDA 510(k) clearance on 1978-02-23. The listed applicant is Norcliff Thayer, Inc.. The 510(k) number is K780174.

When did ORABRITE receive FDA 510(k) clearance?

ORABRITE received FDA 510(k) clearance on 1978-02-23, under 510(k) number K780174.

Who is the listed applicant for ORABRITE?

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

What is the FDA product code for ORABRITE?

The FDA product code for ORABRITE is JER.

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 Norcliff Thayer, 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.

K890290BRACE (ORAFIX SPECIAL)K791576FORGET - DENTURE BONDING LIQUIDK771002ICE BAND

Related Devices (Code: JER)

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.

K883403DENTA PLUSConnoisseurs Products Corp.K881391ULTRASONIC DENTURE CLEANERTatung Company of America, Inc.K872521DENTURE CLEANSERSDental Research LaboratoriesK852906DURACLEAN DENTURE CLEANERAstron Dental Corp.K840805ORAL SAFEGreat Lakes Orthodontics, Ltd.K832359ORAL SAFEGreat Lakes Orthodontics, 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.

↑