Cleared Traditional

K070857 - NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM

K070857 is an FDA 510(k) clearance for NOBELDIRECT 3.0-IMMEDIATE LOAD, 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 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

FDA 510(k) Submission Details - K070857

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.

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 1175
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
ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114
K072660 · Imtec Corp. · Dec 2007
SPI SYSTEM DENTAL IMPLANTS
K072649 · Thommen Medical AG · Dec 2007