Cleared Traditional

K000768 - WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR

K000768 is an FDA 510(k) clearance for WALLACH QUANTUM 500 ELECTROSURGICAL GEN..., manufactured by Wallach Surgical Devices, Inc.. The device is a Class 2 Dental device with product code EKZ cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K000768 · Wallach Surgical Devices, Inc. · Dental device
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Apr 2000
Decision
33d
Days
Class 2
Risk

K000768 is an FDA 510(k) clearance for the WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR. Classified as Unit, Electrosurgical, And Accessories, Dental (product code EKZ), Class II - Special Controls.

Submitted by Wallach Surgical Devices, Inc. (Orange, US). The FDA issued a Cleared decision on April 11, 2000 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4920 - 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 Wallach Surgical Devices, Inc. devices

FDA 510(k) Submission Details - K000768

510(k) Number K000768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2000
Decision Date April 11, 2000
Days to Decision 33 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 127d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EKZ Device Classification - Class 2, Special Controls

Product Code EKZ Unit, Electrosurgical, And Accessories, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4920
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EKZ Unit, Electrosurgical, And Accessories, Dental

All 12
Devices cleared under the same product code (EKZ) and FDA review panel - the closest regulatory comparables to K000768.
THE FUGO BLADE FOR DENTISTRY
K063468 · Medisurg , Ltd. · Apr 2007
MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT
K052622 · Macan Engineering Co. · Dec 2005
MC6A
K050735 · Macan Engineering Co. · May 2005
BI-DENT
K982229 · Valley Forge Scientific Corp. · Aug 1998
ODONTOSURGE 2
K981390 · Periogiene · Jun 1998
ARTHROCARE DENTAL ELECTROSURGERY SYSTEM
K962445 · Arthrocare Corp. · Jul 1996