Cleared Traditional

K980630 - FRIALIT-2 CORABASE

K980630 is an FDA 510(k) clearance for FRIALIT-2 CORABASE, manufactured by Friatec AG. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K980630 · Friatec AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
198d
Days
Class 2
Risk

K980630 is an FDA 510(k) clearance for the FRIALIT-2 CORABASE. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Friatec AG (San Diego, US). The FDA issued a Cleared decision on September 4, 1998 after a review of 198 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Friatec AG devices

FDA 510(k) Submission Details - K980630

510(k) Number K980630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1998
Decision Date September 04, 1998
Days to Decision 198 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
71d slower than avg
Panel avg: 127d · This submission: 198d
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 940
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K980630.
IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES
K982492 · Imcor · Oct 1998
SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT
K982305 · Sulzer Calcitek, Inc. · Sep 1998
VARIOUS DENTAL IMPLANTS
K982111 · Biotech Medical Instruments Corp. · Sep 1998
3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT
K980083 · Implant Innovations, Inc. · Aug 1998
ICON IMPLANT SYSTEM
K974106 · Bio Science Technologies, Inc. · Jun 1998
BRANEMARK SYSTEM DEC 600 DRILLING UNIT
K974123 · Nobel Biocare Uas, Inc. · May 1998