Cleared Traditional

K981459 - MEMBRANE TACK

K981459 is an FDA 510(k) clearance for MEMBRANE TACK, manufactured by Biomet, Inc.. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K981459 · Biomet, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
82d
Days
Class 2
Risk

K981459 is an FDA 510(k) clearance for the MEMBRANE TACK. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 14, 1998 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4880 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet, Inc. devices

FDA 510(k) Submission Details - K981459

510(k) Number K981459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1998
Decision Date July 14, 1998
Days to Decision 82 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
45d faster than avg
Panel avg: 127d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZL Device Classification - Class 2, Special Controls

Product Code DZL Screw, Fixation, Intraosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4880
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 - DZL Screw, Fixation, Intraosseous

All 72
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K981459.
DRG SHERLOCK MF BONE SCREW, COCRMO SELF-TAPPING, TI ALLOY SELF-TAPPING/SELF DRILLING, COCRMO SELF-TAPPING/ SELF DRILLING
K981881 · Doctor'S Research Group, Inc. · Dec 1998
2.5 MM LACTOSORB SCREWS
K981666 · Biomet, Inc. · Nov 1998
QUICK TAP SELF DRILLING SCREW
K982927 · Kinamed, Inc. · Sep 1998
SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR
K981362 · Synthes (Usa) · Jun 1998
SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS
K980199 · Synthes (Usa) · Apr 1998
DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM
K974817 · Doctor'S Research Group, Inc. · Mar 1998