Cleared Traditional

K012032 - FIRST SPEP

K012032 is an FDA 510(k) clearance for FIRST SPEP, manufactured by Bisco, Inc.. The device is a Class 2 Dental device with product code DYH cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K012032 · Bisco, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
80d
Days
Class 2
Risk

K012032 is an FDA 510(k) clearance for the FIRST SPEP. Classified as Adhesive, Bracket And Tooth Conditioner, Resin (product code DYH), Class II - Special Controls.

Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on September 17, 2001 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3750 - 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.

FDA 510(k) Submission Details - K012032

510(k) Number K012032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2001
Decision Date September 17, 2001
Days to Decision 80 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
48d faster than avg
Panel avg: 128d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYH Device Classification - Class 2, Special Controls

Product Code DYH Adhesive, Bracket And Tooth Conditioner, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3750
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 - DYH Adhesive, Bracket And Tooth Conditioner, Resin

All 193
Devices cleared under the same product code (DYH) and FDA review panel - the closest regulatory comparables to K012032.
PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
K020115 · Pulpdent Corp. · Feb 2002
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
K014059 · Pulpdent Corp. · Feb 2002
PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM
K012673 · Prime Dental Manufacturing, Inc. · Oct 2001
VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE
K010544 · Apex Dental Materials, Inc. · Aug 2001
ORTHO VLC
K011521 · First Scientific Limited · Aug 2001
IMPROVED ENLIGHT LV
K001881 · Sybron Dental Specialties, Inc. · Aug 2000
K012032 · FIRST SPEP
Download PDF FDA Summary Bisco, Inc.