Cleared Traditional

K972648 - SONICSYS INLAY

K972648 is an FDA 510(k) clearance for SONICSYS INLAY, manufactured by Ivoclar North America, Inc.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K972648 · Ivoclar North America, Inc. · Dental device
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Oct 1997
Decision
107d
Days
Class 2
Risk

K972648 is an FDA 510(k) clearance for the SONICSYS INLAY. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Ivoclar North America, Inc. (Amherst, US). The FDA issued a Cleared decision on October 30, 1997 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ivoclar North America, Inc. devices

FDA 510(k) Submission Details - K972648

510(k) Number K972648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1997
Decision Date October 30, 1997
Days to Decision 107 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
20d faster than avg
Panel avg: 127d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 420
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K972648.
PRILANE
K981524 · Gresco Products, Inc. · Jul 1998
CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN
K981000 · European Dental Imports, Inc. · May 1998
PROCAD
K980986 · Ivoclar USA, Inc. · May 1998
VINTAGE HALO
K973247 · Shofu Dental Corp. · Oct 1997
IPS EMPRESS COSMO INGOT
K972827 · Ivoclar North America, Inc. · Sep 1997
FINESSE ALL-CERAMIC SYSTEM
K971869 · Dentsply Intl. · Sep 1997