Cleared Traditional

K082800 - STAR/VENT INTERNAL HEX SCREW IMPLANT

K082800 is an FDA 510(k) clearance for STAR/VENT INTERNAL HEX SCREW IMPLANT, manufactured by Park Dental Research Corp.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 701-day FDA review.

K082800 · Park Dental Research Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
701d
Days
Class 2
Risk

K082800 is an FDA 510(k) clearance for the STAR/VENT INTERNAL HEX SCREW IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Park Dental Research Corp. (Washington, US). The FDA issued a Cleared decision on August 26, 2010 after a review of 701 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Park Dental Research Corp. devices

FDA 510(k) Submission Details - K082800

510(k) Number K082800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2008
Decision Date August 26, 2010
Days to Decision 701 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
574d slower than avg
Panel avg: 127d · This submission: 701d
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 759
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K082800.
HT III SA FIXTURE SYSTEM
K101096 · Hiossen, Inc. · Oct 2010
TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT
K101880 · Zimmer Dental, Inc. · Oct 2010
TAPERED SCREW-VENT T IMPLANT
K101977 · Zimmer Dental, Inc. · Sep 2010
MODIFICATION TO: HG III ULTRA WIDE SYSTEM
K093889 · Hiossen, Inc. · Apr 2010
BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM
K093321 · BioHorizons Implant Systems, Inc. · Apr 2010
SPI DENTAL IMPLANT, ELEMENT
K093615 · Thommen Medical AG · Mar 2010