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)

ENHANCE DENTAL RESTORATIVE

K-Number: K811443 · 1981-06-16

ApplicantJohnson & Johnson Professionals, Inc.
Decision Date1981-06-16
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENHANCE DENTAL RESTORATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Professionals, Inc.. It received FDA 510(k) clearance on 1981-06-16 under 510(k) number K811443. 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 ENHANCE DENTAL RESTORATIVE?

ENHANCE DENTAL RESTORATIVE is a medical device that received FDA 510(k) clearance on 1981-06-16. The listed applicant is Johnson & Johnson Professionals, Inc.. The 510(k) number is K811443.

When did ENHANCE DENTAL RESTORATIVE receive FDA 510(k) clearance?

ENHANCE DENTAL RESTORATIVE received FDA 510(k) clearance on 1981-06-16, under 510(k) number K811443.

Who is the listed applicant for ENHANCE DENTAL RESTORATIVE?

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

What is the FDA product code for ENHANCE DENTAL RESTORATIVE?

The FDA product code for ENHANCE DENTAL RESTORATIVE 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 Johnson & Johnson Professionals, 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.

K992173SIPHONGUARD CSF CONTROL DEVICEK991413CODMAN ETHISORB DURA PATCHK991222CODMAN MICROSENSOR VENTRICULAR CATHETER KITK982379SUNDT SLIM-LINE ANEURYSM CLIP APPLIERK982812G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER)K983141CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS

View all 206 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.

↑