Cleared Traditional

K011130 - PREMIUM

K011130 is an FDA 510(k) clearance for PREMIUM, 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 83-day FDA review.

K011130 · Heraeus Kulzer, Inc. · Dental device
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Jul 2001
Decision
83d
Days
Class 2
Risk

K011130 is an FDA 510(k) clearance for the PREMIUM. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Heraeus Kulzer, Inc. (Armonk, US). The FDA issued a Cleared decision on July 5, 2001 after a review of 83 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 - K011130

510(k) Number K011130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2001
Decision Date July 05, 2001
Days to Decision 83 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
44d faster than avg
Panel avg: 127d · This submission: 83d
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 16
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K011130.
CONDYLAFORM II NFC
K060565 · Ivoclar Vivadent, Inc. · May 2006
ARTIC
K033628 · Heraeus Kulzer, Inc. · Jan 2004
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
K023035 · Ivoclar Vivadent, Inc. · Dec 2002
SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH
K962456 · Ivoclar North America, Inc. · Aug 1996
NEW TOOTH MATERIAL
K920684 · Dentsply Intl. · Dec 1992
VITAPAN ACRYLIC DENTURE TEETH
K914476 · Vident · Mar 1992