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SILFRADENT srl SB P3001

by Silfradent SRL

Ref SB P3001

SILFRADENT srl SB P3001 is a device classified as Class IIa in the EU and Class II in the US made by Silfradent SRL, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI B-08056093310337), cleared under FDA 510(k) K083569 on 1 Apr 2009 and listed in FDA GUDID since 1 Mar 2017 (UDI-DI 08056093310337), active as of 25 Oct 2026.

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 found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K083569

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08056093310337 Basic UDI-DI 08056093310337UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056093310337 UDI-DI Date1 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Abbreviated NumberK083569 Date1 Apr 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08056093310337 registered 7 Oct 2026 Active
  • FDA 510(k) K083569 decided 1 Apr 2009 Active
  • FDA GUDID UDI-DI 08056093310337 listed 1 Mar 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K083569
  2. Listed FDA GUDID 08056093310337
  3. Registered EUDAMED B-08056093310337

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  • Withdrawn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
Inserto per chirurgia piezoelettrica EUDAMED
SILFRADENT srl GUDID
Generic name
Ultrasonic dental scaling/debridement system
Device name
Inserto per chirurgia piezoelettrica SB P3001
Model / reference
SB P3001
Primary DI / UDI-DI
08056093310337
Basic UDI-DI
B-08056093310337
510(k) Number
FDA product code
DZI
EMDN code
Q010399 Surgical dental devices - other
GMDN term
Ultrasonic dental scaling/debridement system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.4120
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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: Ultrasonic dental scaling/debridement system

Cleared under the same submission (K083569)

and 8 more cleared under K083569

Similar devices in this category

Other devices filed under SURGICAL DENTAL DEVICES - OTHER.

Other devices from Silfradent SRL

See all devices from Silfradent SRL →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)