Cleared Traditional

K990381 - TOTALBOND

K990381 is an FDA 510(k) clearance for TOTALBOND, manufactured by Parkell, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K990381 · Parkell, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
98d
Days
Class 2
Risk

K990381 is an FDA 510(k) clearance for the TOTALBOND. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Parkell, Inc. (Farmingdale, US). The FDA issued a Cleared decision on May 17, 1999 after a review of 98 days - within the typical 510(k) review window.

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: 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 Parkell, Inc. devices

FDA 510(k) Submission Details - K990381

510(k) Number K990381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1999
Decision Date May 17, 1999
Days to Decision 98 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
29d faster than avg
Panel avg: 127d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

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 421
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K990381.
FUTURA GLASS IONOMER SILVER REINFORCED
K991974 · Ab Ardent · Sep 1999
NEXUS 2
K992160 · Sybron Dental Specialties, Inc. · Aug 1999
BISTITE II SC
K991711 · Tokuyama America, Inc. · Jul 1999
IONOSIT BOND
K991172 · Dmg Chemisch Pharmazeutische Fabrik GmbH · May 1999
HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010
K990155 · Kay See Dental Mfg. Co. · Feb 1999
MIRACLE MIX POWDER/LIQUID
K984505 · GC America, Inc. · Feb 1999