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Take 1

by Sybron Dental Specialties, Inc.

510(k) K003808

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 NumberK003808 Date1 Mar 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  • Withdrawn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, 21 Sep 2026

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

This device is a dental impression material. It is classified as a Class II medical device under FDA regulation number 872.3660.

The device received FDA 510(k) clearance (K003808) on March 1, 2001, as substantially equivalent to a predicate device. It is manufactured by Sybron Dental Specialties, Inc. in Orange, California.

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Questions

AI-generated answers, 21 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 TAKE 1 used for?

    TAKE 1 is a dental impression material used to create accurate molds of teeth and oral structures for dental prosthetics, crowns, bridges, and other restorative procedures.

  • Who manufactures TAKE 1 and where is it produced?

    TAKE 1 is manufactured by Sybron Dental Specialties, Inc. at their facility located at 1717 W. Collins Ave., Orange, California, 92867, United States.

  • What regulatory pathway was used for TAKE 1's market authorization?

    TAKE 1 received FDA 510(k) clearance under K003808 on March 1, 2001, demonstrating substantial equivalence to a legally marketed predicate device under Class II regulations.