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)

COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM

K-Number: K870266 · 1987-02-27

ApplicantColtene, Inc.
Decision Date1987-02-27
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coltene, Inc.. It received FDA 510(k) clearance on 1987-02-27 under 510(k) number K870266. 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 COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM?

COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM is a medical device that received FDA 510(k) clearance on 1987-02-27. The listed applicant is Coltene, Inc.. The 510(k) number is K870266.

When did COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM receive FDA 510(k) clearance?

COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM received FDA 510(k) clearance on 1987-02-27, under 510(k) number K870266.

Who is the listed applicant for COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM?

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

What is the FDA product code for COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM?

The FDA product code for COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM 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 Coltene, 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.

K902392COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIALK882800COLTENE PRESIDENT JET REGULAR BODYK873671COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEMK870047COLTENE RAPIDK863998COLTENE JET-MIXERK850036COLTENE PRECISE

View all 13 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.

↑