Skip to content

CompuDent STA Drive Unit STA-5220

by Milestone Scientific Inc.

Ref STA-5220-220

CompuDent STA Drive Unit STA-5220 is a device classified as Class IIa in the EU and Class II in the US made by Milestone Scientific Inc., registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI B-00618874112042), cleared under FDA 510(k) K061904 on 8 Aug 2006 and listed in FDA GUDID since 13 Jun 2023 (UDI-DI 00618874112042), active as of 8 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K061904

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00618874112042 Basic UDI-DI 00618874112042UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00618874112042 UDI-DI Date13 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK061904 Date8 Aug 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00618874112042 registered 22 Sep 2026 Active
  • FDA 510(k) K061904 decided 8 Aug 2006 Active
  • FDA GUDID UDI-DI 00618874112042 listed 13 Jun 2023 Listed

Recalls

1 recall · FDA

    • Terminated Z-1952-2015 FDA Class III initiated 11 Feb 2015

    Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument.

Timeline

4 dated events

  1. Cleared FDA 510(k) K061904
  2. Recall initiated FDA recalls Z-1952-2015
  3. Listed FDA GUDID 00618874112042
  4. Registered EUDAMED B-00618874112042

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
CompuDent-STA™ Drive Unit EUDAMED
CompuDent STA Drive Unit GUDID
Generic name
Electric infusion pump administration set, single-use
Model / reference
STA-5220-220 EUDAMED
STA-5220 GUDID
Primary DI / UDI-DI
00618874112042
Basic UDI-DI
B-00618874112042
510(k) Number
FDA product code
EJI
EMDN code
Z12110199 Instruments for dental treatment units - other
GMDN term
Electric infusion pump administration set, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.6770
EU registration type
Legacy device (under a directive)
EU market of registration
Poland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
STA-5220-220
GUDID
STA-5220
Device classEUDAMED
Class IIa
GUDID
Class II
Supplied sterileEUDAMED
No
GUDID
Yes

Registry differences

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

  • Supplied sterile UDI-DI 00618874112042: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Electric infusion pump administration set, single-use

Cleared under the same submission (K061904)

and 7 more cleared under K061904

Similar devices in this category

Other devices filed under INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER.

Other devices from Milestone Scientific Inc.

See all devices from Milestone Scientific Inc. →

Properties

  • Supplied sterile NoEUDAMEDYesGUDID
  • Single use
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)