Cleared Traditional

K063523 - ZIMMER ONE PIECE IMPLANT

Also marketed or referenced as:
ZOP37A10, 11, 13, 16 ZOP47S10, 11, 13, 16 ZOP4

K063523 is the FDA 510(k) clearance for ZIMMER ONE PIECE IMPLANT by Zimmer Dental, Inc.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K063523 · Zimmer Dental, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
86d
Days
Class 2
Risk

K063523 is an FDA 510(k) clearance for the ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Zimmer Dental, Inc. (Carlsbad, US). The FDA issued a Cleared decision on February 16, 2007 after a review of 86 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.

View all Zimmer Dental, Inc. devices

Submission Details

510(k) Number K063523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2006
Decision Date February 16, 2007
Days to Decision 86 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
41d faster than avg
Panel avg: 127d · This submission: 86d
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 K063523.
ZIRCONIA IMPLANT
K061971 · Nobel Biocare AB · Mar 2007
CERTAIN PREVAIL DENTAL IMPLANT
K061629 · Implant Innovations, Inc. · Feb 2007
NANOTITE DENTAL IMPLANTS
K062432 · Implant Innovations, Inc. · Feb 2007
SFB AND CFB IMPLANTS - 5.0 PLATFORM
K063718 · Nobel Biocare AB · Jan 2007
NOBELPERFECT CONICAL CONNECTION
K062936 · Nobel Biocare AB · Dec 2006
US SYSTEM
K062030 · Osstem Implant Co., Ltd. · Nov 2006