Cleared Traditional

K982305 - SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT

K982305 is an FDA 510(k) clearance for SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ..., manufactured by Sulzer Calcitek, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K982305 · Sulzer Calcitek, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
83d
Days
Class 2
Risk

K982305 is an FDA 510(k) clearance for the SPLINE DENTAL IMPLANT SYSTEM-TEMPORARY ABUTMENT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sulzer Calcitek, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 83 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 Sulzer Calcitek, Inc. devices

FDA 510(k) Submission Details - K982305

510(k) Number K982305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1998
Decision Date September 22, 1998
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
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 939
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K982305.
STERNGOLD IMPLAMED WIDE PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTTUMENTATION
K983786 · Sterngold/Implamed · Nov 1998
FRIALIT-2 AUROBASE MODEL NUMBERS 45-2446, 45-2456, 45-2466, 45-2476
K982576 · Friatec AG · Oct 1998
IMCOR DENTAL IMPLANT SYSTEM ACCESSORIES
K982492 · Imcor · Oct 1998
VARIOUS DENTAL IMPLANTS
K982111 · Biotech Medical Instruments Corp. · Sep 1998
FRIALIT-2 CORABASE
K980630 · Friatec AG · Sep 1998
3I ORTHODONTIC ABUTMENT, ORTHOBUTMENT
K980083 · Implant Innovations, Inc. · Aug 1998