Skip to content

Dentsply ProRoot Flex Tip PRFT20

by Nusmile, Ltd

Ref PRFT20

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00883205034BFT20EP Basic UDI-DI 00810118106637UDI-DIDate11 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810118106637 UDI-DI Date14 Jan 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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
Dentsply ProRoot Flex Tip
Generic Name
Dental material injection cannula, single-use
Device Name
Basic Flex Tip
Model / Reference
PRFT20
Primary DI / UDI-DI
00810118106637
Basic UDI-DI
00883205034BFT20EP
EMDN Code
Q019006 Dental material application tips and brushes, single-use
GMDN Term
Dental material injection cannula, single-use
Device Class
Class I
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Other devices from Nusmile, Ltd

See all devices from Nusmile, Ltd →

Properties

  • Single Use
  • Convenience Kit
  • Combination Product
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No