Cleared Traditional

K023035 - SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER

K023035 is an FDA 510(k) clearance for SR VIVOTAC/SR ORTHOTAC, manufactured by Ivoclar Vivadent, Inc.. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K023035 · Ivoclar Vivadent, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2002
Decision
81d
Days
Class 2
Risk

K023035 is an FDA 510(k) clearance for the SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on December 2, 2002 after a review of 81 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 - K023035

510(k) Number K023035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2002
Decision Date December 02, 2002
Days to Decision 81 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 128d · This submission: 81d
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 53
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K023035.
VALPLAST YAMAHACHI TEETH
K060507 · Valplast Intl. Corp. · Apr 2006
ARTIC
K033628 · Heraeus Kulzer, Inc. · Jan 2004
ARTEGRAL AND POLYSTAR SELECTION
K030588 · Merz Dental GmbH · May 2003
TRILUX, Z-TONE, ACRY ROCK
K022299 · Ruthibras Imp. Exp. Com. DE Materiais Odontologico · Oct 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
K023035 · SR VIVOTAC/SR ORTHOTAC, MODIFIER MONOMER & POLYMER
Download PDF FDA Summary Ivoclar Vivadent, Inc.