Cleared Traditional

K981526 - ACE ALVEOLAR DISTRACTOR

K981526 is an FDA 510(k) clearance for ACE ALVEOLAR DISTRACTOR, manufactured by Ace Surgical Supply Co., Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K981526 · Ace Surgical Supply Co., Inc. · Dental device
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Nov 1998
Decision
192d
Days
Class 2
Risk

K981526 is an FDA 510(k) clearance for the ACE ALVEOLAR DISTRACTOR. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Ace Surgical Supply Co., Inc. (Brockton, US). The FDA issued a Cleared decision on November 6, 1998 after a review of 192 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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 - K981526

510(k) Number K981526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 1998
Decision Date November 06, 1998
Days to Decision 192 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
65d slower than avg
Panel avg: 127d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 - JEY Plate, Bone

All 197
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K981526.
NORMED BONE TRANSPORT
K990140 · Ace Surgical Supply Co., Inc. · Mar 1999
BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES
K983885 · Howmedica, Inc. · Jan 1999
MICRO DYNAMIC MESH
K983528 · Howmedica Corp. · Dec 1998
SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES
K981890 · Synthes (Usa) · Aug 1998
LACTOSORB PANELS AND FASTENERS
K980927 · Biomet, Inc. · Jun 1998
20-HOLE ADAPTATION PLATE
K981070 · Biomet, Inc. · May 1998