Cleared Traditional

K022299 - TRILUX, Z-TONE, ACRY ROCK

K022299 is an FDA 510(k) clearance for TRILUX, manufactured by Ruthibras Imp. Exp. Com. DE Materiais Odontologico. 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.

K022299 · Ruthibras Imp. Exp. Com. DE Materiais Odontologico · Dental device
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Oct 2002
Decision
83d
Days
Class 2
Risk

K022299 is an FDA 510(k) clearance for the TRILUX, Z-TONE, ACRY ROCK. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Ruthibras Imp. Exp. Com. DE Materiais Odontologico (Littleton, US). The FDA issued a Cleared decision on October 7, 2002 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.

FDA 510(k) Submission Details - K022299

510(k) Number K022299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2002
Decision Date October 07, 2002
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
45d faster than avg
Panel avg: 128d · 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 52
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K022299.
ARTIC
K033628 · Heraeus Kulzer, Inc. · Jan 2004
ARTEGRAL AND POLYSTAR SELECTION
K030588 · Merz Dental GmbH · May 2003
SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
K023035 · Ivoclar Vivadent, Inc. · Dec 2002
ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V
K022300 · Dental Vipi Ltda · Oct 2002
ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V AND Z-TONE PREFORMED PLASTIC DENTURE TEETH
K013824 · Dental Manufacturing S.P.A · Jan 2002
PREMIUM
K011130 · Heraeus Kulzer, Inc. · Jul 2001
K022299 · TRILUX, Z-TONE, ACRY ROCK
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