Cleared Traditional

K811889 - R & S SERIES FITTING TOOLS

K811889 is an FDA 510(k) clearance for R & S SERIES FITTING TOOLS, manufactured by Suncoast Dental Corp.. The device is a Class 1 Dental device with product code EIC cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K811889 · Suncoast Dental Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1981
Decision
23d
Days
Class 1
Risk

K811889 is an FDA 510(k) clearance for the R & S SERIES FITTING TOOLS. Classified as Syringe, Periodontic, Endodontic, Irrigating (product code EIC), Class I - General Controls.

Submitted by Suncoast Dental Corp. (Walker, US). The FDA issued a Cleared decision on July 24, 1981 after a review of 23 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 Suncoast Dental Corp. devices

FDA 510(k) Submission Details - K811889

510(k) Number K811889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1981
Decision Date July 24, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 128d · This submission: 23d
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 K811889.
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