Cleared Traditional

K974628 - FRIALIT-2 PROTECT ABUTMENT

K974628 is an FDA 510(k) clearance for FRIALIT-2 PROTECT ABUTMENT, 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 90-day FDA review.

K974628 · Friatec AG · Dental device
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Mar 1998
Decision
90d
Days
Class 2
Risk

K974628 is an FDA 510(k) clearance for the FRIALIT-2 PROTECT ABUTMENT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Friatec AG (Potomac, US). The FDA issued a Cleared decision on March 11, 1998 after a review of 90 days - within the typical 510(k) review window.

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 - K974628

510(k) Number K974628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1997
Decision Date March 11, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
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 K974628.
ASTRA TECH IMPLANTS - DENTAL SYSTEM
K980698 · Astra Tech, Inc. · Mar 1998
REPLACE CYLINDRICAL IMPLANTS
K980439 · Steri-Oss, Inc. · Mar 1998
CRYSTAL AND CRYSTAL-SEAL IMPLANTS SYSTEM
K980442 · Crystal Medical Technology · Mar 1998
IMPLANT SITE DILATORS
K980374 · BioHorizons Implant Systems, Inc. · Mar 1998
3.25MM SIMPLER THREADED DENTAL IMPLANT
K974856 · Vancouver Implant Resources, Inc. · Feb 1998
4.0MM SIMPLER THREADED DENTAL IMPLANT
K974857 · Vancouver Implant Resources, Inc. · Feb 1998