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FDA 510(k)

HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT

K-Number: K861846 · 1986-06-26

ApplicantSolar Dental Co., Inc.
Decision Date1986-06-26
Product CodeEIC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Solar Dental Co., Inc.. It received FDA 510(k) clearance on 1986-06-26 under 510(k) number K861846. The device is classified under product code EIC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT?

HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT is a medical device that received FDA 510(k) clearance on 1986-06-26. The listed applicant is Solar Dental Co., Inc.. The 510(k) number is K861846.

When did HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT receive FDA 510(k) clearance?

HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT received FDA 510(k) clearance on 1986-06-26, under 510(k) number K861846.

Who is the listed applicant for HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT?

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

What is the FDA product code for HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT?

The FDA product code for HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT is EIC.

Related Clinical Trials

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Other records listing Solar Dental Co., 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.

K871980D-23 DENTURE ADHESIVEK852926DENTOLOCK II DENTURE ADHESIVE CREAMK831294SOLARCRY/TEMPORARY CROWN & BRIDGE MATK831293SOLARCRYL CUSTOM TRAY MATERIALK831265DENTOLOCK DENTURE ADHESIVE CREAM

Related Devices (Code: EIC)

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.

K972234RCT GEL ROOT CANAL THERAPY GELDentsply Intl.K864307MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI)Smith & Nephew, Inc.K851944MAX-I-PROBE HANDPIECESolo Pak LaboratoriesK840237MAX-I-PROBE PERIODONTAL ENDODONTIC PROBSmith & Nephew, Mpl DivisionK811889R & S SERIES FITTING TOOLSSuncoast Dental Corp.K811594WATER PISTOLAus-Tex Dental Mfg. & Design

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.

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