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DuoTEMP 5830

by Coltène/Whaledent AG

DuoTEMP 5830 is a Class II device made by Coltène/Whaledent AG, cleared under FDA 510(k) K072604 on 16 Nov 2007 and listed in FDA GUDID since 15 Aug 2016 (UDI-DI J00658300), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K072604

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberJ00658300 UDI-DI Date15 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK072604 Date16 Nov 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K072604 decided 16 Nov 2007 Active
  • FDA GUDID UDI-DI J00658300 listed 15 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K072604
  2. Listed FDA GUDID J00658300

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DuoTEMP
Generic name
Zinc phosphate dental cement
Model / Ref / Catalog
5830
Primary DI / UDI-DI
J00658300
510(k) Number
FDA product code
EMA
GMDN term
Zinc phosphate dental cement
Device class
Class II
Regulation number
872.3275
GUDID distribution status
In Commercial Distribution

Related devices

Category: Zinc phosphate dental cement

Cleared under the same submission (K072604)

Other devices from Coltène/Whaledent AG

See all devices from Coltène/Whaledent AG →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)