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Pent Core Plus (Paste-Paste)

by Jeneric/Pentron, Inc.

510(k) K941373

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK941373 Date3 May 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pent Core Plus (Paste-Paste) is a tooth shade resin material, classified as a dental composite filling. It is designed to restore carious lesions or structural defects in teeth using materials such as bisphenol-A glycidyl methacrylate (Bis-GMA). This device falls under the product code EBF and is intended for use in restorative dental procedures.

This device is supplied as a paste-paste system and is regulated under FDA 510(k) clearance (K941373) as a Class II dental device with special controls. It is intended for single-use applications in clinical settings and requires proper handling and storage as per manufacturer guidelines. No additional regulatory status beyond the stated FDA clearance is implied.

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