Cleared Traditional

K962456 - SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH

K962456 is an FDA 510(k) clearance for SR ANTARIS ANTERIOR TEETH/SR POSTARIS P..., manufactured by Ivoclar North America, Inc.. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K962456 · Ivoclar North America, Inc. · Dental device
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Aug 1996
Decision
42d
Days
Class 2
Risk

K962456 is an FDA 510(k) clearance for the SR ANTARIS ANTERIOR TEETH/SR POSTARIS POSTERIOR TEETH. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on August 6, 1996 after a review of 42 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 Ivoclar North America, Inc. devices

FDA 510(k) Submission Details - K962456

510(k) Number K962456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1996
Decision Date August 06, 1996
Days to Decision 42 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
85d faster than avg
Panel avg: 127d · This submission: 42d
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 31
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K962456.
ARTIFICIAL TEETH (ACRYLIC TEETH)
K992854 · Masterdent Ltda. · Feb 2000
NATURA DENTURE TEETH
K984134 · Davis Schottlander & Davis, Ltd. · Feb 1999
ENIGMA DENTURE TEETH
K984128 · Davis Schottlander & Davis, Ltd. · Feb 1999
COMPATIT R
K913582 · Wilde-USA, Inc. · Jun 1993
NEW TOOTH MATERIAL
K920684 · Dentsply Intl. · Dec 1992
VITAPAN ACRYLIC DENTURE TEETH
K914476 · Vident · Mar 1992