Cleared Traditional

K931868 - PRIMADRY PRODUCT LINE

K931868 is an FDA 510(k) clearance for PRIMADRY PRODUCT LINE, manufactured by Ultradent Products, Inc.. The device is a Class 2 Dental device with product code EBC cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K931868 · Ultradent Products, Inc. · Dental device
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Jul 1993
Decision
99d
Days
Class 2
Risk

K931868 is an FDA 510(k) clearance for the PRIMADRY PRODUCT LINE. Classified as Sealant, Pit And Fissure, And Conditioner (product code EBC), Class II - Special Controls.

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3765 - 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 Ultradent Products, Inc. devices

FDA 510(k) Submission Details - K931868

510(k) Number K931868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1993
Decision Date July 22, 1993
Days to Decision 99 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
28d faster than avg
Panel avg: 127d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBC Device Classification - Class 2, Special Controls

Product Code EBC Sealant, Pit And Fissure, And Conditioner
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3765
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 - EBC Sealant, Pit And Fissure, And Conditioner

All 104
Devices cleared under the same product code (EBC) and FDA review panel - the closest regulatory comparables to K931868.
PULPDENT SEAL-RITE LOW VISCOSITY
K932794 · Pulpdent Corp. · Sep 1993
HELIOSEAL F
K932078 · Ivoclar North America, Inc. · Sep 1993
SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT
K931857 · Confi-Dental Products Co. · Jul 1993
ULTRASEAL XT PIT AND FISSURE SEALANT PRODUCT LINE
K931869 · Ultradent Products, Inc. · Jul 1993
BARITONE C2, MODIFICATION
K932002 · Confi-Dental Products Co. · Jul 1993
ALPHA-DENT PIT AND FISSURE SEALANT
K924635 · Wallace A. Erickson & Co. · Oct 1992