Cleared Traditional

K994376 - FRIALIT-2 3.4MM STEEPED CYLINDER IMPLAN...

Also marketed or referenced as:
FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA

K994376 is an FDA 510(k) clearance for FRIALIT-2 3.4MM STEEPED CYLINDER IMPLAN..., manufactured by Friadent GmbH. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K994376 · Friadent GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
88d
Days
Class 2
Risk

K994376 is an FDA 510(k) clearance for the FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Friadent GmbH (Lake Forest, US). The FDA issued a Cleared decision on March 24, 2000 after a review of 88 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 Friadent GmbH devices

FDA 510(k) Submission Details - K994376

510(k) Number K994376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1999
Decision Date March 24, 2000
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 127d · This submission: 88d
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 837
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K994376.
INPLANT ORTHODONTIC ANCHOR SYSTEM
K000643 · Nobel Biocare Uas, Inc. · Sep 2000
FRIALIT-2 MH-2 ABUTMENT
K994174 · Friadent GmbH · Apr 2000
BRANEMARK NOVUM
K000018 · Nobel Biocare Uas, Inc. · Mar 2000
SYNOCTA ANGLED ABUTMENTS
K994119 · Straumann USA · Mar 2000
LIFECORE SINGLE TOOTH ABUTMENT SYSTEM
K993894 · Lifecore Biomedical, Inc. · Mar 2000
DENTAL IMPLANT
K992937 · Nobel Biocare Uas, Inc. · Feb 2000