Cleared Traditional

K060994 - MONDIAL

K060994 is an FDA 510(k) clearance for MONDIAL, manufactured by Heraeus Kulzer, Inc.. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K060994 · Heraeus Kulzer, Inc. · Dental device
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May 2006
Decision
41d
Days
Class 2
Risk

K060994 is an FDA 510(k) clearance for the MONDIAL. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on May 22, 2006 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3590 - 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 Heraeus Kulzer, Inc. devices

FDA 510(k) Submission Details - K060994

510(k) Number K060994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2006
Decision Date May 22, 2006
Days to Decision 41 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
86d faster than avg
Panel avg: 127d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELM Device Classification - Class 2, Special Controls

Product Code ELM Denture, Plastic, Teeth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3590
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 - ELM Denture, Plastic, Teeth

All 32
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K060994.
REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH
K070591 · Union Dental S.A./Unidesa.Odi · May 2007
CURATIVE DENTAL ACRYLIC TEETH
K060720 · Curative, LLC · Aug 2006
WIEDENT ESTETIC
K061337 · Xpdent Corp · Jun 2006
CONDYLAFORM II NFC
K060565 · Ivoclar Vivadent, Inc. · May 2006
VALPLAST YAMAHACHI TEETH
K060507 · Valplast Intl. Corp. · Apr 2006
ARTIC
K033628 · Heraeus Kulzer, Inc. · Jan 2004