Cleared Traditional

K982229 - BI-DENT

K982229 is an FDA 510(k) clearance for BI-DENT, manufactured by Valley Forge Scientific Corp.. The device is a Class 2 Dental device with product code EKZ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K982229 · Valley Forge Scientific Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
90d
Days
Class 2
Risk

K982229 is an FDA 510(k) clearance for the BI-DENT. Classified as Unit, Electrosurgical, And Accessories, Dental (product code EKZ), Class II - Special Controls.

Submitted by Valley Forge Scientific Corp. (Oaks, US). The FDA issued a Cleared decision on August 13, 1998 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. 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 Valley Forge Scientific Corp. devices

FDA 510(k) Submission Details - K982229

510(k) Number K982229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1998
Decision Date August 13, 1998
Days to Decision 90 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
38d faster than avg
Panel avg: 128d · This submission: 90d
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 16
Devices cleared under the same product code (EKZ) and FDA review panel - the closest regulatory comparables to K982229.
BONART ART-E1 ELECTROSURGERY UNIT
K020080 · Diagnostic Data, Inc. · Feb 2002
ODONTOSURGE 3
K001560 · Odonto-Wave · Aug 2000
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
K000768 · Wallach Surgical Devices, Inc. · Apr 2000
ODONTOSURGE 2
K981390 · Periogiene · Jun 1998
ARTHROCARE DENTAL ELECTROSURGERY SYSTEM
K962445 · Arthrocare Corp. · Jul 1996
DENTO-SURGE
K955176 · Ellman Intl., Inc. · Apr 1996