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Dischetti Protettivi

by Rhein 83 S.r.l. 2 variants

Part of a family of 32 devices: see the family page

Ref 100PDR

Dischetti Protettivi (100PDR) is a Class I device made by Rhein 83 S.r.l., registered in EUDAMED on 20 Mar 2026 (Basic UDI-DI 805804571DPRLL) and listed in FDA GUDID since 30 Jul 2021 (UDI-DI 08059224004440), active as of 22 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number805804571DPRLL Basic UDI-DI 08059224004440UDI-DIDate20 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08059224004440 UDI-DI Date30 Jul 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 805804571DPRLL registered 20 Mar 2026 Active
  • FDA GUDID UDI-DI 08059224004440 listed 30 Jul 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08059224004440
  2. Registered EUDAMED 805804571DPRLL

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  • Withdrawn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
Direct Titanium Attachments
Generic name
Dental implant suprastructure, permanent, preformed
Device name
Dischetti Protettivi
Model / Ref / Catalog
100PDR, PINK PROTECTIVE DISKS pz.10
Primary DI / UDI-DI
08059224004440
Basic UDI-DI
805804571DPRLL
FDA product code
EGG
EMDN code
Q010207 Dental impression devices for prosthetic dentistry
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class I
Regulation number
872.3165
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
100PDR
GUDID
PINK PROTECTIVE DISKS pz.10
ImplantableEUDAMED
No
GUDID
Yes

Manufacturer details

EUDAMED SRN
IT-MF-000005998

Similar devices in this category

Other devices filed under DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY.

Other devices from Rhein 83 S.r.l.

See all devices from Rhein 83 S.r.l. →

Properties

  • Sterilise before use
  • Single use
  • Implantable NoEUDAMEDYesGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)