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)

ARTIFICIAL TEETH, PORCELAIN, MODIFIED

K-Number: K860608 · 1986-03-26

ApplicantDentsply Intl.
Decision Date1986-03-26
Product CodeELL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARTIFICIAL TEETH, PORCELAIN, MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1986-03-26 under 510(k) number K860608. The device is classified under product code ELL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTIFICIAL TEETH, PORCELAIN, MODIFIED?

ARTIFICIAL TEETH, PORCELAIN, MODIFIED is a medical device that received FDA 510(k) clearance on 1986-03-26. The listed applicant is Dentsply Intl.. The 510(k) number is K860608.

When did ARTIFICIAL TEETH, PORCELAIN, MODIFIED receive FDA 510(k) clearance?

ARTIFICIAL TEETH, PORCELAIN, MODIFIED received FDA 510(k) clearance on 1986-03-26, under 510(k) number K860608.

Who is the listed applicant for ARTIFICIAL TEETH, PORCELAIN, MODIFIED?

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 ARTIFICIAL TEETH, PORCELAIN, MODIFIED?

The FDA product code for ARTIFICIAL TEETH, PORCELAIN, MODIFIED is ELL.

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: ELL)

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.

K240586Additive Manufacturing Zirconia Customized RestorationHangzhou Thales Medtech Co., Ltd.K203072Franz Zirconia Dental CrownFranz Biotech, Inc.K162043NobelProcera HT ML FCZ BridgeNobel Biocare ABK153534NobelProcera HT ML Full Contour Zirconia CrownNobel Biocare ABK071182PROCERA BRIDGE ZIRCONIA 9 UNITS-14 UNITS, MODELS 30-4004 TO 30-4013Nobel Biocare ABK060530SD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING. MODEL 45301. RD CERAMIC COPING FOR QUICK ABUTMENT, LOCKING, MODEL 45302.Lifecore Biomedical, 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.

↑