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Emulate Advanced

by Cavex Holland BV

510(k) K072245

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK072245 Date8 Nov 2007ClearedStatusActive

Official records

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  • Withdrawn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, 23 Sep 2026

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

Emulate Advanced is a dental impression material classified as a Class II medical device under FDA regulation 872.3660. It received traditional 510(k) clearance (K072245) on November 8, 2007, and was found substantially equivalent to a predicate device. The device is intended for use in dental applications as an impression material.

The device is manufactured by Cavex Holland BV and is supplied as a non-sterile, single-use or reusable material depending on clinical protocol. It is not MRI conditional or labeled for specific sterility; storage and handling should follow manufacturer instructions. No specific sizes or storage conditions are detailed in the provided data.

Devices cleared under K072245

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K072245
UDI-DISize and differences
EMULATE 3904-732
BENCO DENTAL SUPPLY CO.
3904-732D74439047320 —On the market
EMULATE 3904-778
BENCO DENTAL SUPPLY CO.
3904-778D74439047781 —On the market

Similar devices

Other devices filed under FDA product code ELW (Material, Impression).

Other devices from Cavex Holland BV

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