Cleared Traditional

K853788 - DB PRECISION IMPLANT SYSTEM

K853788 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 51-day FDA review.

K853788 · Driskell Bioengineering · Dental device
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Oct 1985
Decision
51d
Days
Class 2
Risk

K853788 is an FDA 510(k) clearance for the DB PRECISION IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Driskell Bioengineering (Westerville, US). The FDA issued a Cleared decision on October 31, 1985 after a review of 51 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 - K853788

510(k) Number K853788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1985
Decision Date October 31, 1985
Days to Decision 51 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 128d · This submission: 51d
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 K853788.
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
PYROLITE CARBON ENDOSSEOUS DENTAL IMPL
K791237 · Carbomedics, Inc. · Aug 1979