Cleared Traditional

K983876 - MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE ACRYLIC

K983876 is an FDA 510(k) clearance for MILLENIUM SLEDGEHAMMER, manufactured by Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind. The device is a Class 2 Dental device with product code EBI cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K983876 · Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
44d
Days
Class 2
Risk

K983876 is an FDA 510(k) clearance for the MILLENIUM SLEDGEHAMMER, FORMULA 99 AND NATURALYKE H.C., HIGH IMPACT DENTURE A.... Classified as Resin, Denture, Relining, Repairing, Rebasing (product code EBI), Class II - Special Controls.

Submitted by Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind (Cherry Hill, US). The FDA issued a Cleared decision on December 16, 1998 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3760 - 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 Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind devices

FDA 510(k) Submission Details - K983876

510(k) Number K983876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1998
Decision Date December 16, 1998
Days to Decision 44 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 127d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBI Device Classification - Class 2, Special Controls

Product Code EBI Resin, Denture, Relining, Repairing, Rebasing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3760
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 - EBI Resin, Denture, Relining, Repairing, Rebasing

All 217
Devices cleared under the same product code (EBI) and FDA review panel - the closest regulatory comparables to K983876.
RESIN 4
K981862 · Harry J. Bosworth Co. · Feb 1999
STERNVANTAGE VARNISH LC, MODEL 221001
K984341 · Sterngold/Implamed · Jan 1999
PROTECH PLUS
K983547 · Protech, Inc. · Jan 1999
MUCOPREN SOFT RELINING SYSTEM
K983357 · Roydent Dental Products, Inc. · Nov 1998
SILICONE SOFT RELINE
K981691 · Harry J. Bosworth Co. · Nov 1998
GC RELINE
K982695 · GC America, Inc. · Oct 1998