Cleared Traditional

K954605 - ACE CYLINDER DENTAL IMPLANT

K954605 is an FDA 510(k) clearance for ACE CYLINDER DENTAL IMPLANT, manufactured by Ace Surgical Supply Co., Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K954605 · Ace Surgical Supply Co., Inc. · Dental device
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Jun 1996
Decision
245d
Days
Class 2
Risk

K954605 is an FDA 510(k) clearance for the ACE CYLINDER DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Ace Surgical Supply Co., Inc. (Brockton, US). The FDA issued a Cleared decision on June 5, 1996 after a review of 245 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 Ace Surgical Supply Co., Inc. devices

FDA 510(k) Submission Details - K954605

510(k) Number K954605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1995
Decision Date June 05, 1996
Days to Decision 245 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 127d · This submission: 245d
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 792
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K954605.
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CERA ONE ABUTMENT SYSTEM
K961737 · Nobelpharma USA, Inc. · Jul 1996
ACE SREW DENTLA IMPLANT SYSTEM
K954513 · Ace Surgical Supply Co., Inc. · Jun 1996
STERI-OSS 6MM DIAMETER TPS COATED IMPLANTS
K961020 · Steri-Oss, Inc. · Jun 1996
SCREW EXTRACTION DEVICE AND THREAD CLEANING TAP
K960979 · Steri-Oss, Inc. · May 1996
ABUTMENT SELECTION KIT
K960639 · Nobelpharma USA, Inc. · May 1996