Cleared Traditional

K022300 - ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N.H., VIPI DENT V

K022300 is an FDA 510(k) clearance for ACRY PAN, manufactured by Dental Vipi Ltda. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K022300 · Dental Vipi Ltda · Dental device
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Oct 2002
Decision
79d
Days
Class 2
Risk

K022300 is an FDA 510(k) clearance for the ACRY PAN, VIPI DENT PLUS, BIOLUX, BIOLUX V, NEW DENT, DENTOLUXX, VIPI DENT N..... Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Dental Vipi Ltda (Littleton, US). The FDA issued a Cleared decision on October 3, 2002 after a review of 79 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 Vipi Ltda devices

FDA 510(k) Submission Details - K022300

510(k) Number K022300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2002
Decision Date October 03, 2002
Days to Decision 79 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
48d faster than avg
Panel avg: 127d · This submission: 79d
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 K022300.
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