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NaviTip Tips

by Ultradent Products, Inc. 13 variants

Part of a family of 59 devices: see the family page

Ref 4992

NaviTip Tips (4992) is a Class I device made by Ultradent Products, Inc., registered in EUDAMED on 20 Apr 2026 (Basic UDI-DI 0883205-TF032AQ) and listed in FDA GUDID since 8 Dec 2022 (UDI-DI 00883205033116), active as of 25 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0883205-TF032AQ Basic UDI-DI 00883205033116UDI-DIDate20 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00883205033116 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0883205-TF032AQ registered 20 Apr 2026 Active
  • FDA GUDID UDI-DI 00883205033116 listed 8 Dec 2022 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 00883205033116
  2. Registered EUDAMED 0883205-TF032AQ

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  • Withdrawn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
NaviTip Tips EUDAMED
NaviTip 29G Sideport GUDID
Generic name
Dental material injection cannula, single-use
Device name
Tips
Model / Ref / Catalog
4992
Primary DI / UDI-DI
00883205033116
Basic UDI-DI
0883205-TF032AQ
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

Manufacturer details

EUDAMED SRN
US-MF-000013697
Authorised representative
Ultradent Products GmbH DE-AR-000006666

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