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Rhodia Dental Putty Impression Material

by Rhodia, Inc.

510(k) K013129

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 NumberK013129 Date10 Oct 2001ClearedStatusActive

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  • Withdrawn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
ELW
Device Class
Class II
Regulation
21 CFR Part 872.3660
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.

Rhodia Dental Putty Impression Material is a two-part vinyl polysiloxane impression material. It utilizes an addition-cure reaction and is intended for use in dental procedures.

The base and catalyst components are mixed manually by dental professionals prior to application. The material is used for first impressions in double impression techniques and is compatible with metal or plastic perforated and non-perforated trays.

Other devices from Rhodia, 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 Rhodia Dental Putty Impression Material used for?

    Rhodia Dental Putty Impression Material is intended for use in dental procedures, specifically for first impressions in double impression techniques, as it is a two-part vinyl polysiloxane impression material that utilizes an addition-cure reaction.

  • How is Rhodia Dental Putty Impression Material supplied and prepared for use?

    The material is supplied as separate base and catalyst components that are mixed manually by dental professionals prior to application, allowing for on-site preparation before use in dental impressions.

  • Is Rhodia Dental Putty Impression Material compatible with different types of dental trays?

    Yes, the material is compatible with both metal and plastic perforated and non-perforated trays, providing flexibility in clinical use depending on the practitioner's preference and procedural requirements.