Cleared Traditional

K913688 - BUD MAXILLOFACIAL IMPLANT SYSTEM

K913688 is an FDA 510(k) clearance for BUD MAXILLOFACIAL IMPLANT SYSTEM, manufactured by Bud Industries, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K913688 · Bud Industries, Inc. · Dental device
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May 1992
Decision
260d
Days
Class 2
Risk

K913688 is an FDA 510(k) clearance for the BUD MAXILLOFACIAL IMPLANT SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Bud Industries, Inc. (Holland, US). The FDA issued a Cleared decision on May 5, 1992 after a review of 260 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 Bud Industries, Inc. devices

FDA 510(k) Submission Details - K913688

510(k) Number K913688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1991
Decision Date May 05, 1992
Days to Decision 260 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 127d · This submission: 260d
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 257
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K913688.
OSTEOMED M3 SYSTEM (SBF SYSTEM)
K924138 · Osteomed Corp. · Feb 1993
LORENZ 1.0 MM SYSTEM
K922741 · Walter Lorenz Surgical, Inc. · Dec 1992
MODIFICATION TECHMEDICA MP (MINIPLATING) SYSTEM
K921801 · Techmedica, Inc. · Jul 1992
LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM
K910038 · Walter Lorenz Surgical, Inc. · Feb 1991
LUHR MICRO MESH
K901940 · Howmedica Corp. · Sep 1990
LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES
K901941 · Howmedica Corp. · Sep 1990