Cleared Traditional

K922651 - ACE DENTAL IMPLANT KIT

K922651 is an FDA 510(k) clearance for ACE DENTAL IMPLANT KIT, manufactured by Ace Surgical Supply Co., Inc.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 586-day FDA review.

K922651 · Ace Surgical Supply Co., Inc. · Dental device
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Jan 1994
Decision
586d
Days
Class 1
Risk

K922651 is an FDA 510(k) clearance for the ACE DENTAL IMPLANT KIT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Ace Surgical Supply Co., Inc. (Brockton, US). The FDA issued a Cleared decision on January 10, 1994 after a review of 586 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Ace Surgical Supply Co., Inc. devices

FDA 510(k) Submission Details - K922651

510(k) Number K922651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1992
Decision Date January 10, 1994
Days to Decision 586 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
459d slower than avg
Panel avg: 127d · This submission: 586d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIA Unit, Operative Dental

All 81
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K922651.
A-DEC CASCADE 3072 WALLMOUNT
K935325 · A-Dec, Inc. · Apr 1994
ACE BASIC DENTAL IMPLANT PACK II
K922649 · Ace Surgical Supply Co., Inc. · Jan 1994
ACE DENTAL IMPLANT CUSTOM SURGICAL PACK
K922650 · Ace Surgical Supply Co., Inc. · Jan 1994
ACE BASIC DENTAL IMPLANT PACK I
K922652 · Ace Surgical Supply Co., Inc. · Jan 1994
A-DEC 2544 DOCTORS IC MICRO-CART
K925797 · A-Dec, Inc. · Jan 1994
A-DEC 2545 DUO IC MICRO-CART
K925798 · A-Dec, Inc. · Jan 1994