Cleared Traditional

K780929 - COTTON TIPPED POINT

K780929 is an FDA 510(k) clearance for COTTON TIPPED POINT, manufactured by Young Dental Manufacturing Co. 1, LLC. The device is a Class 1 General Hospital device with product code KXF cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K780929 · Young Dental Manufacturing Co. 1, LLC · General Hospital
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Jun 1978
Decision
25d
Days
Class 1
Risk

K780929 is an FDA 510(k) clearance for the COTTON TIPPED POINT. Classified as Applicator, Absorbent Tipped, Non-sterile (product code KXF), Class I - General Controls.

Submitted by Young Dental Manufacturing Co. 1, LLC (Mchenry, US). The FDA issued a Cleared decision on June 30, 1978 after a review of 25 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6025 - the FDA general hospital device 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 Young Dental Manufacturing Co. 1, LLC devices

FDA 510(k) Submission Details - K780929

510(k) Number K780929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1978
Decision Date June 30, 1978
Days to Decision 25 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 129d · This submission: 25d
Pathway characteristics
Predicate-based equivalence.

KXF Device Classification - Class 1, General Controls

Product Code KXF Applicator, Absorbent Tipped, Non-sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6025
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 - KXF Applicator, Absorbent Tipped, Non-sterile

All 10
Devices cleared under the same product code (KXF) and FDA review panel - the closest regulatory comparables to K780929.
PREP SET CAT.#908
K802020 · Pollak (Intl.), Ltd. · Sep 1980
DEXIDE DISPOSABLE PREP STICK
K791168 · Dexide, Inc. · Jul 1979
DEXIDE DISPOSABLE SWAB STICK
K791169 · Dexide, Inc. · Jul 1979
SHAVE PREP
K780604 · Abco Dealers, Inc. · Apr 1978
CATH KIT, SUPERPUBIC
K772227 · American Hospital Supply Corp. · Dec 1977
Q-TIPS
K770433 · Chesebrough-Pond'S U.S.A. Co. · Apr 1977