Cleared Traditional

K890290 - BRACE (ORAFIX SPECIAL)

K890290 is an FDA 510(k) clearance for BRACE (ORAFIX SPECIAL), manufactured by Norcliff Thayer, Inc.. The device is a Class 1 Dental device with product code ECB cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K890290 · Norcliff Thayer, Inc. · Dental device
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Mar 1989
Decision
69d
Days
Class 1
Risk

K890290 is an FDA 510(k) clearance for the BRACE (ORAFIX SPECIAL). Classified as Unit, Syringe, Air And/or Water (product code ECB), Class I - General Controls.

Submitted by Norcliff Thayer, Inc. (Tarrytown, US). The FDA issued a Cleared decision on March 29, 1989 after a review of 69 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 Norcliff Thayer, Inc. devices

FDA 510(k) Submission Details - K890290

510(k) Number K890290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1989
Decision Date March 29, 1989
Days to Decision 69 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 128d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

ECB Device Classification - Class 1, General Controls

Product Code ECB Unit, Syringe, Air And/or Water
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 - ECB Unit, Syringe, Air And/or Water

Devices cleared under the same product code (ECB) and FDA review panel - the closest regulatory comparables to K890290.
DENTAL SYRINGE TIP
K931137 · A-Dec, Inc. · Nov 1993
PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE
K923285 · Smith & Nephew, Inc. · Sep 1992
POSTERIOR NASAL EPISTAXIS INSTRUMENTS
K911756 · Richard Wolf Medical Instruments Corp. · Oct 1991
SERINGA TRIPLICE S.L.
K863024 · Sds Dental, Inc. · Sep 1986
TUBING SYRING
K854699 · Almore Intl., Inc. · Jan 1986
SPACELINE THREE WAY SYRINGE
K801686 · Pacific Dental Corp. · Aug 1980