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)

RESTOBOND 4

K-Number: K924378 · 1993-03-31

ApplicantLee Pharmaceuticals
Decision Date1993-03-31
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RESTOBOND 4 is the device name listed in this FDA 510(k) record. The listed applicant is Lee Pharmaceuticals. It received FDA 510(k) clearance on 1993-03-31 under 510(k) number K924378. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESTOBOND 4?

RESTOBOND 4 is a medical device that received FDA 510(k) clearance on 1993-03-31. The listed applicant is Lee Pharmaceuticals. The 510(k) number is K924378.

When did RESTOBOND 4 receive FDA 510(k) clearance?

RESTOBOND 4 received FDA 510(k) clearance on 1993-03-31, under 510(k) number K924378.

Who is the listed applicant for RESTOBOND 4?

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 RESTOBOND 4?

The FDA product code for RESTOBOND 4 is KLE.

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.

K912256PRECISE(R) BETA QUARTZ GLASS-CERAMIC INSERTK900809LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETSK894315RESTOBOND 3/DENTIN-ENAMEL BONDING AGENTK881903PROSTHODENT VLK873123LEE COMPOSITE INLAY SYSTEMK863157RESTODENT POSTERIOR

View all 29 devices →

Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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.

↑