Cleared Traditional

K955337 - OPAKER

K955337 is an FDA 510(k) clearance for OPAKER, manufactured by Kerr Dental Materials Center. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K955337 · Kerr Dental Materials Center · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
63d
Days
Class 2
Risk

K955337 is an FDA 510(k) clearance for the OPAKER. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kerr Dental Materials Center (Glendora, US). The FDA issued a Cleared decision on January 23, 1996 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Kerr Dental Materials Center devices

FDA 510(k) Submission Details - K955337

510(k) Number K955337 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1995
Decision Date January 23, 1996
Days to Decision 63 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
64d faster than avg
Panel avg: 127d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 708
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K955337.
KOLOR +
K961284 · Sybron Dental Specialties, Inc. · May 1996
ALPHA-DENT COMPOSITE SURFACE SEALANT
K960165 · Wallace A. Erickson & Co. · Mar 1996
CRYSTALLESSENCE
K954988 · Confi-Dental Products Co. · Mar 1996
AELITEFLO
K955292 · Bisco, Inc. · Dec 1995
CHARISMA SINGLE DOSE
K954929 · Heraeus Kulzer, Inc. · Nov 1995
AMERICAN DENTAL PRODDUCTS LIGHT ACTIVATED COMPOSITE RESIN CORE PASTE WITH FLUORIDE
K954405 · American Dental Products, Inc. · Oct 1995