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RC-Prep 9007139

by Premier Dental Products Company

Ref 9007139

RC-Prep 9007139 is a Class I device made by Premier Dental Products Company, registered in EUDAMED on 5 Jun 2026 (Basic UDI-DI 00348783RC-PrepTipsRC) and listed in FDA GUDID since 29 Jun 2022 (UDI-DI 00348783005141), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00348783RC-PrepTipsRC Basic UDI-DI 00348783005141UDI-DIDate5 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00348783005141 UDI-DI Date29 Jun 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 00348783RC-PrepTipsRC registered 5 Jun 2026 Active
  • FDA GUDID UDI-DI 00348783005141 listed 29 Jun 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 00348783005141
  2. Registered EUDAMED 00348783RC-PrepTipsRC

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  • Withdrawn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
Rc-Prep 3cc Syringe Tip Refill (50) EUDAMED
RC-Prep GUDID
Generic name
Dental material injection cannula, single-use
Device name
RC-Prep Tips
Model / reference
9007139
Primary DI / UDI-DI
00348783005141
Basic UDI-DI
00348783RC-PrepTipsRC
FDA product code
KXR
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
872.3140
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

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 Premier Dental Products Company

See all devices from Premier Dental Products Company →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)