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)

ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE

K-Number: K802125 · 1980-09-16

ApplicantDentsply Intl.
Decision Date1980-09-16
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1980-09-16 under 510(k) number K802125. 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 ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE?

ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE is a medical device that received FDA 510(k) clearance on 1980-09-16. The listed applicant is Dentsply Intl.. The 510(k) number is K802125.

When did ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE receive FDA 510(k) clearance?

ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE received FDA 510(k) clearance on 1980-09-16, under 510(k) number K802125.

Who is the listed applicant for ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE?

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

What is the FDA product code for ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE?

The FDA product code for ANTERIOR/POSTERIOR COMPOSITE 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 Dentsply Intl. 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.

K123615IRIS - HIGH STRENGTH GLASS CERAMICK072730FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTSK070538XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVEK070019CARRARA VOLUMIAK061427PRE-IMPRESSION CONDITIONING SOLUTIONK052334CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131

View all 279 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.

↑