Cleared Traditional

K061003 - SFB & CFB IMPLANTS

K061003 is an FDA 510(k) clearance for SFB & CFB IMPLANTS, manufactured by Nobel Biocare AB. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K061003 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
80d
Days
Class 2
Risk

K061003 is an FDA 510(k) clearance for the SFB & CFB IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Nobel Biocare AB (Yorba Linda,, US). The FDA issued a Cleared decision on June 30, 2006 after a review of 80 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.

FDA 510(k) Submission Details - K061003

510(k) Number K061003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2006
Decision Date June 30, 2006
Days to Decision 80 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
48d faster than avg
Panel avg: 128d · This submission: 80d
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 1548
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K061003.
STRAUMANN DENTAL IMPLANTS
K061176 · Institut Straumann AG · Aug 2006
ENHANCE DENTAL IMPLANT SYSTEM
K061335 · Coastal Biocare · Aug 2006
SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS
K061500 · Sic Invent AG · Aug 2006
ENDOSSEOUS DENTAL IMPLANT
K061169 · Northern Implants, LLC · Jun 2006
SPEEDY ORTHODONTIC SCREW
K060500 · Dentium Co., Ltd. · Jun 2006
IMPLANTIUM II
K060501 · Dentium Co., Ltd. · Jun 2006
K061003 · SFB & CFB IMPLANTS
Download PDF FDA Summary Nobel Biocare AB