Cleared Traditional

K861846 - HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT

K861846 is an FDA 510(k) clearance for HYDRON ROOT CANAL FILLING & MARK IV STA..., manufactured by Solar Dental Co., Inc.. The device is a Class 1 Dental device with product code EIC cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K861846 · Solar Dental Co., Inc. · Dental device
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Jun 1986
Decision
44d
Days
Class 1
Risk

K861846 is an FDA 510(k) clearance for the HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT. Classified as Syringe, Periodontic, Endodontic, Irrigating (product code EIC), Class I - General Controls.

Submitted by Solar Dental Co., Inc. (Chicago, US). The FDA issued a Cleared decision on June 26, 1986 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Solar Dental Co., Inc. devices

FDA 510(k) Submission Details - K861846

510(k) Number K861846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1986
Decision Date June 26, 1986
Days to Decision 44 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 128d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

EIC Device Classification - Class 1, General Controls

Product Code EIC Syringe, Periodontic, Endodontic, Irrigating
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIC Syringe, Periodontic, Endodontic, Irrigating

All 7
Devices cleared under the same product code (EIC) and FDA review panel - the closest regulatory comparables to K861846.
RCT GEL ROOT CANAL THERAPY GEL
K972234 · Dentsply Intl. · Jun 1997
MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI)
K864307 · Smith & Nephew, Inc. · Nov 1986
MARK IV SYRINGE
K801483 · National Patent Development Corp. · Jul 1980
ROOT CANAL FILLING APPLICATOR NEEDLES
K801484 · National Patent Development Corp. · Jul 1980
CENTRIX MKIV ENDODONTIC DELIVERY
K792461 · Centrix, Inc. · Dec 1979
SYRINGE, ENDODONTIC, W/PERFORATED NEEDLE
K770967 · National Patent Development Corp. · Jun 1977