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)

REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT

K-Number: K861546 · 1986-05-21

ApplicantMacrochem Corp.
Decision Date1986-05-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT is the device name listed in this FDA 510(k) record. The listed applicant is Macrochem Corp.. It received FDA 510(k) clearance on 1986-05-21 under 510(k) number K861546. 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 REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT?

REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT is a medical device that received FDA 510(k) clearance on 1986-05-21. The listed applicant is Macrochem Corp.. The 510(k) number is K861546.

When did REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT receive FDA 510(k) clearance?

REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT received FDA 510(k) clearance on 1986-05-21, under 510(k) number K861546.

Who is the listed applicant for REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT?

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

What is the FDA product code for REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT?

The FDA product code for REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT 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 Macrochem Corp. 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.

K890623FLUOREVER(R) DUAL CURE CERAMIC VENEER CEMENTK890608FLUOREVER(R) LIGHT CURE CERAMIC VENEER CEMENTK890494FLUOREVER PIT AND FISSURE SEALANT OR FLUOREVER PFSK880562ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT

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.

↑