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C-18

by Pentron Corp.

510(k) K841267

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 NumberK841267 Date30 Apr 1984ClearedStatusActive

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  • Withdrawn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, 26 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 C-18 is a dental device manufactured by Pentron Corp. It is classified under the dental advisory committee and product code EBF.

This device received FDA 510(k) clearance on April 30, 1984, under the traditional clearance type. It is identified by the K-number K841267.

Other devices from Pentron Corp.

See all devices from Pentron Corp. →

Questions

AI-generated answers, 26 Sep 2026

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

  • What is the C-18 dental device?

    The C-18 is a dental device manufactured by Pentron Corp. It is categorized under the dental advisory committee and is identified by product code EBF.

  • What is the regulatory status of the C-18?

    The C-18 received FDA 510(k) clearance on April 30, 1984. It was processed under the traditional clearance type and determined to be substantially equivalent to other devices, as recorded under K-number K841267.

  • Who is the manufacturer of the C-18?

    The C-18 is manufactured by Pentron Corp., located in McHenry, Illinois, at 803 N. Front St. Suite 3.