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Comp=flow

by Jeneric/Pentron, Inc.

510(k) K952662

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

Overview

The COMP=FLOW dental device is a cutting-edge, substantially equivalent medical device that utilizes advanced technology to provide high-quality dental services. Designed for precise control and ease of use, this device offers a unique combination of features and benefits that set it apart from other similar products on the market.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK952662 Date28 Aug 1995ClearedStatusActive

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  • Withdrawn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

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