Cleared Traditional

K103790 - ACE TRIMARK TRICAM DENTAL IMPLANT

K103790 is an FDA 510(k) clearance for ACE TRIMARK TRICAM DENTAL IMPLANT, manufactured by Ace Surgical Supply Company, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K103790 · Ace Surgical Supply Company, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
234d
Days
Class 2
Risk

K103790 is an FDA 510(k) clearance for the ACE TRIMARK TRICAM DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Ace Surgical Supply Company, Inc. (Brockton, US). The FDA issued a Cleared decision on August 18, 2011 after a review of 234 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 - K103790

510(k) Number K103790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2010
Decision Date August 18, 2011
Days to Decision 234 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
106d slower than avg
Panel avg: 128d · This submission: 234d
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 K103790.
SEVEN IMPLANTS
K103089 · Mis - Implant Technologies , Ltd. · Sep 2011
BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVEL
K111003 · Biodenta Swiss AG · Sep 2011
KJ SUBMERGED SYSTEM
K103810 · Kj Meditech Co., Ltd. · Sep 2011
OSI O-BALL ABUTMENT HEAD IMPLANTS
K110548 · Juell Dental · Jul 2011
OSSEOFUSE DENTAL IMPLANT SYSTEM
K110577 · Dynamic Innovations, Inc. · Jul 2011
INTRA-LOCK DENTAL IMPLANTS WITH BLOSSOM
K103194 · Intra-Lock International, Inc. · Apr 2011
K103790 · ACE TRIMARK TRICAM DENTAL IMPLANT
Download PDF FDA Summary Ace Surgical Supply C…