Cleared Traditional

K003281 - LACTOSORB RAPIDFLAP

K003281 is an FDA 510(k) clearance for LACTOSORB RAPIDFLAP, manufactured by Biomet, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K003281 · Biomet, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
292d
Days
Class 2
Risk

K003281 is an FDA 510(k) clearance for the LACTOSORB RAPIDFLAP. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 7, 2001 after a review of 292 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K003281

510(k) Number K003281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2000
Decision Date August 07, 2001
Days to Decision 292 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
165d slower than avg
Panel avg: 127d · This submission: 292d
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 249
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K003281.
INION CPS 2.0 ORTHOGNATHIC PLATE
K013039 · Inion , Ltd. · Oct 2001
MACROPORE FX, PS, NS, LP
K012413 · Macropore Biosurgery, Inc. · Sep 2001
STRAUMANN GBR SYSTEM
K011698 · Institut Straumann AG · Aug 2001
MACROPOREPX PEDIATRIC SYSTEM
K002207 · Macropore Biosurgery, Inc. · Jul 2001
MODIFICATION TO THE BIOPLATE BIOCLIP CRANIOTOMY FIXATION SYSTEM
K011380 · Bioplate, Inc. · May 2001
SYNTHES (USA) MIDFACE DISTRACTOR
K010499 · Synthes (Usa) · May 2001