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Capillary Tips BFT02

by Ultradent Products, Inc.

Ref BFT02

Capillary Tips BFT02 is a Class I device made by Ultradent Products, Inc., registered in EUDAMED on 11 Jun 2026 (Basic UDI-DI 00883205034BFT20EP) and listed in FDA GUDID since 7 Sep 2024 (UDI-DI 00883205034700), 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00883205034BFT20EP Basic UDI-DI 00883205034700UDI-DIDate11 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205034700 UDI-DI Date7 Sep 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 00883205034BFT20EP registered 11 Jun 2026 Active
  • FDA GUDID UDI-DI 00883205034700 listed 7 Sep 2024 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 00883205034700
  2. Registered EUDAMED 00883205034BFT20EP

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  • Withdrawn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
Avalon Biomed Basic Flex Tip EUDAMED
Capillary Tips GUDID
Avalon Biomed NeoSEALER 2 Basic Flex Tips GUDID
Generic name
Dental material injection cannula, single-use
Device name
Basic Flex Tip
Model / Ref / Catalog
BFT02
Primary DI / UDI-DI
00883205034700, 00810092938293
Basic UDI-DI
00883205034BFT20EP
FDA product code
EIC
EMDN code
Q019006 Dental material application tips and brushes, single-use
GMDN term
Dental material injection cannula, single-use
Device class
Class I
Regulation number
872.4565
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental material injection cannula, single-use

Similar devices in this category

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

Other devices from Ultradent Products, Inc.

See all devices from Ultradent Products, Inc. →

Properties

  • Single use
  • Prescription use YesGUDIDNoGUDID
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date YesGUDIDNoGUDID
Other properties (20, all answered No)