Cleared Traditional

K790600 - HOWMEDICA STRIP CROWN

K790600 is an FDA 510(k) clearance for HOWMEDICA STRIP CROWN, manufactured by Howmedica Corp.. The device is a Class 1 Dental device with product code DZN cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K790600 · Howmedica Corp. · Dental device
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May 1979
Decision
56d
Days
Class 1
Risk

K790600 is an FDA 510(k) clearance for the HOWMEDICA STRIP CROWN. Classified as Instruments, Dental Hand (product code DZN), Class I - General Controls.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1979 after a review of 56 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 - K790600

510(k) Number K790600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1979
Decision Date May 21, 1979
Days to Decision 56 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
72d faster than avg
Panel avg: 128d · This submission: 56d
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 15
Devices cleared under the same product code (DZN) and FDA review panel - the closest regulatory comparables to K790600.
COREFORM MOLDS
K801530 · Sybron Corp. · Jul 1980
HEMO-WEDGE
K790555 · Parker Laboratories, Inc. · Jan 1980
RUWA MATRIX STRIPS
K790599 · Howmedica Corp. · May 1979
ACCOR MATRIX
K790633 · Accor, Inc. · May 1979
WEDGES, RETAINING, MATRIX
K772314 · Den-Mat Corp. · Jan 1978
MATRIX STRIP, DEAD-SOFT
K772316 · Den-Mat Corp. · Jan 1978
K790600 · HOWMEDICA STRIP CROWN
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