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)

ENAMELITE ENAMEL COATING

K-Number: K770109 · 1977-01-24

ApplicantLee Pharmaceuticals
Decision Date1977-01-24
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENAMELITE ENAMEL COATING is the device name listed in this FDA 510(k) record. The listed applicant is Lee Pharmaceuticals. It received FDA 510(k) clearance on 1977-01-24 under 510(k) number K770109. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENAMELITE ENAMEL COATING?

ENAMELITE ENAMEL COATING is a medical device that received FDA 510(k) clearance on 1977-01-24. The listed applicant is Lee Pharmaceuticals. The 510(k) number is K770109.

When did ENAMELITE ENAMEL COATING receive FDA 510(k) clearance?

ENAMELITE ENAMEL COATING received FDA 510(k) clearance on 1977-01-24, under 510(k) number K770109.

Who is the listed applicant for ENAMELITE ENAMEL COATING?

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

What is the FDA product code for ENAMELITE ENAMEL COATING?

The FDA product code for ENAMELITE ENAMEL COATING is EBF.

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 Lee Pharmaceuticals 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.

K924378RESTOBOND 4K912256PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERTK900809LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETSK894315RESTOBOND 3/DENTIN-ENAMEL BONDING AGENTK881903PROSTHODENT VLK873123LEE COMPOSITE INLAY SYSTEM

View all 29 devices →

Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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.

↑