Cleared Traditional

K082800 - STAR/VENT INTERNAL HEX SCREW IMPLANT (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 1541
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K082800.
Adin Long Dental Implant System
K252031 · Adin Dental Implant Systems , Ltd. · Mar 2026
ZENEX Implant System_Short (R-System)
K253334 · Izenimplant Co., Ltd. · Mar 2026
Straumann® BLC Implants - Indication Widening
K252168 · Institut Straumann AG · Mar 2026
Dentis SQ-SL AXEL Fixture
K253493 · Dentis Co., Ltd. · Mar 2026
Nobel Biocare S Series Implants
K252197 · Nobel Biocare AB · Feb 2026
BIORES Dental Implant System
K252286 · Chengdu Besmile Medical Technology Co., Ltd. · Feb 2026