Cleared Traditional

K860982 - DB PRECISION IMPLANT SYSTEM, 2000 SERIES

K860982 is an FDA 510(k) clearance for DB PRECISION IMPLANT SYSTEM, manufactured by Driskell Bioengineering. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K860982 · Driskell Bioengineering · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
39d
Days
Class 2
Risk

K860982 is an FDA 510(k) clearance for the DB PRECISION IMPLANT SYSTEM, 2000 SERIES. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Driskell Bioengineering (Galena, US). The FDA issued a Cleared decision on April 25, 1986 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Driskell Bioengineering devices

FDA 510(k) Submission Details - K860982

510(k) Number K860982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1986
Decision Date April 25, 1986
Days to Decision 39 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 128d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 1331
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K860982.
SUB-VENT (TM) IMPLANT/ENDOSSEOUS BLADE IMPLANT
K861425 · Core-Vent Corp. · Nov 1986
IMZ INTRAMOBILE CYLINDER IMPLANT SYSTEM COMPONENTS
K863680 · Interpore Intl. · Oct 1986
SCREW-VENT (TM) IMPLANT/ENDOSSEOUS SCREW IMPLANT
K861426 · Core-Vent Corp. · Oct 1986
IMZ INTRAMOBILE CYLINDER IMPLANT
K855032 · Interpore Intl. · Mar 1986
HYDROXYLAPATITE COATED ENDOSSEOUS DENT
K840750 · Calcitek, Inc. · Apr 1984
BIOLITE CARBON COATED DENTAL IMPLANT
K791491 · Carbomedics, Inc. · Sep 1979