Cleared Traditional

K110548 - OSI O-BALL ABUTMENT HEAD IMPLANTS

K110548 is an FDA 510(k) clearance for OSI O-BALL ABUTMENT HEAD IMPLANTS, manufactured by Juell Dental. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K110548 · Juell Dental · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
154d
Days
Class 2
Risk

K110548 is an FDA 510(k) clearance for the OSI O-BALL ABUTMENT HEAD IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Juell Dental (Ardmore, US). The FDA issued a Cleared decision on July 29, 2011 after a review of 154 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.

FDA 510(k) Submission Details - K110548

510(k) Number K110548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2011
Decision Date July 29, 2011
Days to Decision 154 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
26d slower than avg
Panel avg: 128d · This submission: 154d
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 1482
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K110548.
BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL
K111003 · Biodenta Swiss AG · Sep 2011
KJ SUBMERGED SYSTEM
K103810 · Kj Meditech Co., Ltd. · Sep 2011
ACE TRIMARK TRICAM DENTAL IMPLANT
K103790 · Ace Surgical Supply Company, Inc. · Aug 2011
OSSEOFUSE DENTAL IMPLANT SYSTEM
K110577 · Dynamic Innovations, Inc. · Jul 2011
INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM
K103194 · Intra-Lock International, Inc. · Apr 2011
BLUE SKY BIO DENTAL IMPLANT SYSTEM
K102034 · Blue Sky Bio, LLC · Apr 2011
K110548 · OSI O-BALL ABUTMENT HEAD IMPLANTS
Download PDF FDA Summary Juell Dental