Cleared Traditional

K790555 - HEMO-WEDGE

K790555 is an FDA 510(k) clearance for HEMO-WEDGE, manufactured by Parker Laboratories, Inc.. The device is a Class 1 Dental device with product code DZN cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K790555 · Parker Laboratories, Inc. · Dental device
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Jan 1980
Decision
304d
Days
Class 1
Risk

K790555 is an FDA 510(k) clearance for the HEMO-WEDGE. Classified as Instruments, Dental Hand (product code DZN), Class I - General Controls.

Submitted by Parker Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1980 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Parker Laboratories, Inc. devices

FDA 510(k) Submission Details - K790555

510(k) Number K790555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1979
Decision Date January 17, 1980
Days to Decision 304 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
177d slower than avg
Panel avg: 127d · This submission: 304d
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 9
Devices cleared under the same product code (DZN) and FDA review panel - the closest regulatory comparables to K790555.
CENTRIX PCR MOLAR MATRIX FORMS (BANDS)
K861581 · Centrix, Inc. · May 1986
DENTAL MATRIX BAND
K822094 · Dentsply Intl. · Aug 1982
COREFORM MOLDS
K801530 · Sybron Corp. · Jul 1980
RUWA MATRIX STRIPS
K790599 · Howmedica Corp. · May 1979
HOWMEDICA STRIP CROWN
K790600 · Howmedica Corp. · May 1979
WEDGES, RETAINING, MATRIX
K772314 · Den-Mat Corp. · Jan 1978