Cleared Traditional

K070857 - NOBELDIRECT 3.0-IMMEDIATE LOAD

K070857 is the FDA 510(k) clearance for NOBELDIRECT 3.0-IMMEDIATE LOAD by Nobel Biocare AB. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K070857 · Nobel Biocare AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
275d
Days
Class 2
Risk

K070857 is an FDA 510(k) clearance for the NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM. 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 December 28, 2007 after a review of 275 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 Nobel Biocare AB devices

Submission Details

510(k) Number K070857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2007
Decision Date December 28, 2007
Days to Decision 275 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
148d slower than avg
Panel avg: 127d · This submission: 275d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 581
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K070857.
BIOHORIZONS INTERNAL IMPLANT SYSTEM
K073268 · BioHorizons Implant Systems, Inc. · Feb 2008
MS SYSTEM (DENTURE)
K072959 · Osstem Implant Co., Ltd. · Feb 2008
MS SYSTEM (PROVISIONAL)
K072871 · Osstem Implant Co., Ltd. · Jan 2008
NOBELPERFECT CONICAL CONNECTION HEXAGONAL IMPLANTS
K072980 · Nobel Biocare AB · Dec 2007
GS FIXTURE SYSTEM
K072896 · Osstem Implant Co., Ltd. · Nov 2007
BIOHORIZONS TAPERED INTERNAL IMPLANT SYSTEM
K071638 · BioHorizons Implant Systems, Inc. · Oct 2007