Cleared Traditional

K981390 - ODONTOSURGE 2

K981390 is an FDA 510(k) clearance for ODONTOSURGE 2, manufactured by Periogiene. The device is a Class 2 Dental device with product code EKZ cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K981390 · Periogiene · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1998
Decision
56d
Days
Class 2
Risk

K981390 is an FDA 510(k) clearance for the ODONTOSURGE 2. Classified as Unit, Electrosurgical, And Accessories, Dental (product code EKZ), Class II - Special Controls.

Submitted by Periogiene (Rockville, US). The FDA issued a Cleared decision on June 11, 1998 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4920 - 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 Periogiene devices

FDA 510(k) Submission Details - K981390

510(k) Number K981390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1998
Decision Date June 11, 1998
Days to Decision 56 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 127d · This submission: 56d
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 9
Devices cleared under the same product code (EKZ) and FDA review panel - the closest regulatory comparables to K981390.
PERFECT TISSUE CONTOURING SYSTEM II
K071632 · Coltene/Whaledent, Inc. · Oct 2007
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
K000768 · Wallach Surgical Devices, Inc. · Apr 2000
BI-DENT
K982229 · Valley Forge Scientific Corp. · Aug 1998
ARTHROCARE DENTAL ELECTROSURGERY SYSTEM
K962445 · Arthrocare Corp. · Jul 1996
DENTO-SURGE
K955176 · Ellman Intl., Inc. · Apr 1996
SENSIMATIC 500SE
K950239 · Parkell, Inc. · Jun 1995