Cleared Traditional

K840984 - INTERDENTAL WEDGES

K840984 is an FDA 510(k) clearance for INTERDENTAL WEDGES, manufactured by Healthco, Inc.. The device is a Class 1 Dental device with product code DZN cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K840984 · Healthco, Inc. · Dental device
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Apr 1984
Decision
38d
Days
Class 1
Risk

K840984 is an FDA 510(k) clearance for the INTERDENTAL WEDGES. Classified as Instruments, Dental Hand (product code DZN), Class I - General Controls.

Submitted by Healthco, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 13, 1984 after a review of 38 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.

FDA 510(k) Submission Details - K840984

510(k) Number K840984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1984
Decision Date April 13, 1984
Days to Decision 38 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 128d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

DZN Device Classification - Class 1, General Controls

Product Code DZN Instruments, Dental Hand
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 - DZN Instruments, Dental Hand

All 12
Devices cleared under the same product code (DZN) and FDA review panel - the closest regulatory comparables to K840984.
DENTAL MATRIX BAND
K071858 · Fly Cast Technologies, Inc. · Aug 2007
CONTACT MOLAR BANDS AND CONTOUR STRIPS
K901919 · Ivoclar North America, Inc. · Jun 1990
CENTRIX PCR MOLAR MATRIX FORMS (BANDS)
K861581 · Centrix, Inc. · May 1986
DENTAL MATRIX BAND
K822094 · Dentsply Intl. · Aug 1982
COLORED WEDGE USED TO SEPARATE TEETH
K821444 · Moyco Industries, Inc. · Jun 1982
COREFORM MOLDS
K801530 · Sybron Corp. · Jul 1980
K840984 · INTERDENTAL WEDGES
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