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Compules Tips Gun 60665900

by Dentsply De Trey GmbH

Ref 60665900

Compules Tips Gun 60665900 is a Class I device made by Dentsply De Trey GmbH, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI ++D010ACC05LL) and listed in FDA GUDID since 10 Aug 2023 (UDI-DI D010606659001), active as of 24 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D010ACC05LL Basic UDI-DI D010606659001UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD010606659001 UDI-DI Date10 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++D010ACC05LL registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI D010606659001 listed 10 Aug 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID D010606659001
  2. Registered EUDAMED ++D010ACC05LL

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Compules Tips Gun
Generic name
Dental material cartridge-plunging applicator, single-component
Model / Ref / Catalog
60665900
Primary DI / UDI-DI
D010606659001
Basic UDI-DI
++D010ACC05LL
Direct marketing DI
D010K1027640
FDA product code
DZN
EMDN code
Q01010199 Dental restoration devices - other
GMDN term
Dental material cartridge-plunging applicator, single-component
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI D010606659001: EUDAMED states Yes, FDA GUDID states No.

Related devices

Category: Dental material cartridge-plunging applicator, single-component

Similar devices in this category

Other devices filed under DENTAL RESTORATION DEVICES - OTHER.

Other devices from Dentsply De Trey GmbH

See all devices from Dentsply De Trey GmbH →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Administering medicine
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)