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)

ENDODONTIC PULP CANAL SPREADER

K-Number: K934714 · 1994-02-14

ApplicantExcellence IN Endodontics, Inc.
Decision Date1994-02-14
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ENDODONTIC PULP CANAL SPREADER is the device name listed in this FDA 510(k) record. The listed applicant is Excellence IN Endodontics, Inc.. It received FDA 510(k) clearance on 1994-02-14 under 510(k) number K934714. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDODONTIC PULP CANAL SPREADER?

ENDODONTIC PULP CANAL SPREADER is a medical device that received FDA 510(k) clearance on 1994-02-14. The listed applicant is Excellence IN Endodontics, Inc.. The 510(k) number is K934714.

When did ENDODONTIC PULP CANAL SPREADER receive FDA 510(k) clearance?

ENDODONTIC PULP CANAL SPREADER received FDA 510(k) clearance on 1994-02-14, under 510(k) number K934714.

Who is the listed applicant for ENDODONTIC PULP CANAL SPREADER?

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

What is the FDA product code for ENDODONTIC PULP CANAL SPREADER?

The FDA product code for ENDODONTIC PULP CANAL SPREADER is ELC.

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

Related Devices (Code: ELC)

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.

K260773Varios Combi Pro2Nakanishi, Inc.K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.AK251689VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)Nakanishi, Inc.K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd.K233844OdneCleanOdne AGK240707Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017)Shenzhen Micro Electric Intelligence Co., Ltd.

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.

↑