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Nic Tone

by Manufacturera Dental Continental S.A. de C.V. 20 variants

Ref 144-0031

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number75063383DentalDamAD Basic UDI-DI 07506338300674UDI-DIDate5 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07506338300674 UDI-DI Date17 Dec 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
Nic Tone EUDAMED
Nic Tone, MDC Dental GUDID
Generic Name
Rubber dam, Hevea-latex
Device Name
Dental Dam
Model / Reference
144-0031 EUDAMED
NIC TONE RUBBER DAM GUDID
Primary DI / UDI-DI
07506338300674
Basic UDI-DI
75063383DentalDamAD
FDA Product Code
EJE
EMDN Code
Q019002 Dentistry dams and hooks, single-use
GMDN Term
Rubber dam, Hevea-latex
Device Class
Class I
Regulation Number
872.6300
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
144-0031
GUDID
NIC TONE RUBBER DAM

Manufacturer details

EUDAMED SRN
MX-MF-000043045
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Manufacturera Dental Continental S.A. de C.V.

See all devices from Manufacturera Dental Continental S.A. de C.V. →

Properties

  • Single Use
  • Contains Latex
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No