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BioGreen 3005105

by Premier Dental Products Company

Ref 3005105

BioGreen 3005105 is a Class I device made by Premier Dental Products Company, registered in EUDAMED on 29 May 2026 (Basic UDI-DI 00856402BioGreenT9) and listed in FDA GUDID since 30 Dec 2016 (UDI-DI 00856402006092), active as of 22 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00856402BioGreenT9 Basic UDI-DI 00856402006092UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00856402006092 UDI-DI Date30 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 00856402BioGreenT9 registered 29 May 2026 Active
  • FDA GUDID UDI-DI 00856402006092 listed 30 Dec 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 00856402006092
  2. Registered EUDAMED 00856402BioGreenT9

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  • Withdrawn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
BioGreen Micro-Applicator - Sample EUDAMED
BioGreen GUDID
Generic name
Dental material application tool, single-use
Model / reference
3005105
Primary DI / UDI-DI
00856402006092
Basic UDI-DI
00856402BioGreenT9
FDA product code
KXR
EMDN code
Q019006 Dental material application tips and brushes, single-use
GMDN term
Dental material application tool, single-use
Device class
Class I
Regulation number
872.3140
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental material application tool, single-use

Similar devices in this category

Other devices filed under DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE.

Other devices from Premier Dental Products Company

See all devices from Premier Dental Products Company →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)