Cleared Traditional

K801530 - COREFORM MOLDS

K801530 is the FDA 510(k) clearance for COREFORM MOLDS by Sybron Corp.. It is a Class 1 Dental device (product code DZN) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K801530 · Sybron Corp. · Dental device
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Jul 1980
Decision
26d
Days
Class 1
Risk

K801530 is an FDA 510(k) clearance for the COREFORM MOLDS. Classified as Instruments, Dental Hand (product code DZN), Class I - General Controls.

Submitted by Sybron Corp. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980 after a review of 26 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 Sybron Corp. devices

Submission Details

510(k) Number K801530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1980
Decision Date July 28, 1980
Days to Decision 26 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
101d faster than avg
Panel avg: 127d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 8
Devices cleared under the same product code (DZN) and FDA review panel - the closest regulatory comparables to K801530.
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
HEMO-WEDGE
K790555 · Parker Laboratories, Inc. · Jan 1980
RUWA MATRIX STRIPS
K790599 · Howmedica Corp. · May 1979
HOWMEDICA STRIP CROWN
K790600 · Howmedica Corp. · May 1979