Cleared Traditional

K010132 - KLOCKNER DENTAL IMPLANTS

K010132 is an FDA 510(k) clearance for KLOCKNER DENTAL IMPLANTS, manufactured by SOADCO, S.L.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 504-day FDA review.

K010132 · SOADCO, S.L. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
504d
Days
Class 2
Risk

K010132 is an FDA 510(k) clearance for the KLOCKNER DENTAL IMPLANTS, MODELS SK, NK, IK, S3, AND S4. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by SOADCO, S.L. (Escaldes-Engordany, AD). The FDA issued a Cleared decision on June 4, 2002 after a review of 504 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all SOADCO, S.L. devices

FDA 510(k) Submission Details - K010132

510(k) Number K010132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2001
Decision Date June 04, 2002
Days to Decision 504 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
377d slower than avg
Panel avg: 127d · This submission: 504d
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 759
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K010132.
ABUTMENT AND PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
K022859 · Straumann USA · Sep 2002
VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT
K012473 · Vident · Sep 2002
REPLACE SCALLOPED MARGIN IMPLANT SYSTEM
K021584 · Nobel Biocare Uas, Inc. · Jun 2002
REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162
K020646 · Nobel Biocare Uas, Inc. · May 2002
OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES
K014235 · Implant Innovations, Inc. · May 2002
MODIFICATION TO THE MAESTRO SYSTEM
K020645 · BioHorizons Implant Systems, Inc. · Mar 2002