Cleared Traditional

K981335 - ARISTON PHC LINER

K981335 is the FDA 510(k) clearance for ARISTON PHC LINER by Ivoclar North America, Inc.. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K981335 · Ivoclar North America, Inc. · Dental device
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Jul 1998
Decision
80d
Days
Class 2
Risk

K981335 is an FDA 510(k) clearance for the ARISTON PHC LINER. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on July 2, 1998 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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

Submission Details

510(k) Number K981335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1998
Decision Date July 02, 1998
Days to Decision 80 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
47d faster than avg
Panel avg: 127d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 284
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K981335.
GLASIONOMER CEMENT CX PLUS
K982461 · Shofu Dental Corp. · Aug 1998
LIQUID A
K981618 · Harry J. Bosworth Co. · Jul 1998
FLOWABLE COMPOSITE
K981965 · Dentsply Intl. · Jul 1998
MIRACLE MIX CAPSULE
K981370 · GC America, Inc. · Jun 1998
JUMBO GLASS IONOMER CEMENT
K980568 · Centrix, Inc. · Apr 1998
PROTEC CEM.
K980922 · Ivoclar North America, Inc. · Apr 1998