Cleared Traditional

K982951 - IMTEC BIOPIN

K982951 is an FDA 510(k) clearance for IMTEC BIOPIN, manufactured by Imtec Corp.. The device is a Class 2 Dental device with product code DZL cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K982951 · Imtec Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
301d
Days
Class 2
Risk

K982951 is an FDA 510(k) clearance for the IMTEC BIOPIN. Classified as Screw, Fixation, Intraosseous (product code DZL), Class II - Special Controls.

Submitted by Imtec Corp. (Ardmore, US). The FDA issued a Cleared decision on June 21, 1999 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Imtec Corp. devices

FDA 510(k) Submission Details - K982951

510(k) Number K982951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1998
Decision Date June 21, 1999
Days to Decision 301 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
174d slower than avg
Panel avg: 127d · This submission: 301d
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 76
Devices cleared under the same product code (DZL) and FDA review panel - the closest regulatory comparables to K982951.
KLS-MARTIN MMF SCREW
K980760 · KLS-Martin L.P. · Dec 1999
TALON ANCHOR SNAP-PAK
K993327 · Mitek Products · Dec 1999
MITEK MINI ANCHOR
K992623 · Mitek Products · Nov 1999
LORENZ IMF SCREW
K983728 · Walter Lorenz Surgical, Inc. · May 1999
SYNTHES 1.3 MM SELF-DRILLING SCREW
K983485 · Synthes (Usa) · Dec 1998
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