Cleared Traditional

K061335 - ENHANCE DENTAL IMPLANT SYSTEM

K061335 is an FDA 510(k) clearance for ENHANCE DENTAL IMPLANT SYSTEM, manufactured by Coastal Biocare. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K061335 · Coastal Biocare · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
89d
Days
Class 2
Risk

K061335 is an FDA 510(k) clearance for the ENHANCE DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Coastal Biocare (San Diego, US). The FDA issued a Cleared decision on August 9, 2006 after a review of 89 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 - K061335

510(k) Number K061335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2006
Decision Date August 09, 2006
Days to Decision 89 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
39d faster than avg
Panel avg: 128d · This submission: 89d
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 1529
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K061335.
SM IMPLANT SYSTEMS
K061797 · Dio Department Dsi, Inc. · Sep 2006
STRAUMANN NARROW NECK IMPLANTS
K060958 · Straumann USA · Aug 2006
STRAUMANN DENTAL IMPLANTS
K061176 · Institut Straumann AG · Aug 2006
SICACE DENTAL IMPLANT SYSTEM AND SIC ANGLED ABUTMENTS
K061500 · Sic Invent AG · Aug 2006
SFB & CFB IMPLANTS
K061003 · Nobel Biocare AB · Jun 2006
ENDOSSEOUS DENTAL IMPLANT
K061169 · Northern Implants, LLC · Jun 2006
K061335 · ENHANCE DENTAL IMPLANT SYSTEM
Download PDF FDA Summary Coastal Biocare