Cleared Traditional

K013824 - ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH

K013824 is an FDA 510(k) clearance for ACRY PLUS, manufactured by Dental Manufacturing S.P.A. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K013824 · Dental Manufacturing S.P.A · Dental device
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Jan 2002
Decision
72d
Days
Class 2
Risk

K013824 is an FDA 510(k) clearance for the ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED .... Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Dental Manufacturing S.P.A (Littleton, US). The FDA issued a Cleared decision on January 30, 2002 after a review of 72 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 Dental Manufacturing S.P.A devices

FDA 510(k) Submission Details - K013824

510(k) Number K013824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2001
Decision Date January 30, 2002
Days to Decision 72 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 127d · This submission: 72d
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 28
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K013824.
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
PREMIUM
K011130 · Heraeus Kulzer, Inc. · Jul 2001
WILLI GELLER CREAPEARL
K010160 · Jensen Industries, Inc. · Mar 2001
ARTIFICIAL TEETH (ACRYLIC TEETH)
K992854 · Masterdent Ltda. · Feb 2000