Cleared Traditional

K862926 - SURGICAL VITEX

K862926 is an FDA 510(k) clearance for SURGICAL VITEX, manufactured by Jeneric Ind.. The device is a Class 2 Dental device with product code ELE cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K862926 · Jeneric Ind. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1986
Decision
28d
Days
Class 2
Risk

K862926 is an FDA 510(k) clearance for the SURGICAL VITEX. Classified as Implant, Subperiosteal (product code ELE), Class II - Special Controls.

Submitted by Jeneric Ind. (Wallingford, US). The FDA issued a Cleared decision on August 29, 1986 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3645 - 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 Jeneric Ind. devices

FDA 510(k) Submission Details - K862926

510(k) Number K862926 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1986
Decision Date August 29, 1986
Days to Decision 28 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 127d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELE Device Classification - Class 2, Special Controls

Product Code ELE Implant, Subperiosteal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3645
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.