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The.r.mo.free

by Dentamax, Inc.

510(k) K990448

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 NumberK990448 Date23 Mar 1999ClearedStatusActive

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  • Withdrawn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
EBI
Device Class
Class II
Regulation
21 CFR Part 872.3760
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 R Mo Free is a dental device used for the fabrication or repair of bases for partial or full dentures. It is classified as a Class 2 dental device with product code EBI.

The device is supplied by Dentamax, Inc. and has been cleared through the Traditional 510(k) pathway. It is available with the product code EBI and k number K990448. The device was cleared on March 23, 1999, after a 39-day FDA review.

Other devices from Dentamax, Inc.

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 R Mo Free device used for?

    The R Mo Free is used for the fabrication or repair of bases for partial or full dentures, as a Class 2 dental device.

  • How is the R Mo Free device supplied?

    The device is supplied by Dentamax, Inc. with product code EBI and k number K990448.

  • What is the regulatory status of the R Mo Free device?

    The device was cleared through the Traditional 510(k) pathway on March 23, 1999, after a 39-day FDA review.