FDA Registration Number: 8023007

Last Validated: December 05, 2023

Status: Valid

Valid2023 U.S. FDA Medical Device Establishment Registration

FFDM TIVOLY

Establishment Information

78-80 AV DE LA PROSPECTIVE
BOURGES CEDEX Centre-Val de Loire, FR 18020
33-2-48-23-27-37

U.S. Agent and Official Correspondent

Registrar Corp
144 Research Drive
Hampton VA, USA 23666
+1-757-224-0177
Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by U.S. FDA.

Listings on file with FDA

Device Name Product Code Status Last Validated  
Spreader, Pulp Canal Filling Material, Endodontic EKK Valid December 04, 2023

Device Listing

Device Name

Spreader, Pulp Canal Filling Material, Endodontic

Product Code

EKK

Company Function(s)

Contract Manufacturer, Manufacturer, Foreign Exporter

Proprietary Name(s)

Spreader, Pulp Canal Filling Material
Paste Filler
Lentulo
File, Pulp Canal, Endodontic EKS Valid December 04, 2023

Device Listing

Device Name

File, Pulp Canal, Endodontic

Product Code

EKS

Company Function(s)

Contract Manufacturer, Foreign Exporter, Manufacturer

Proprietary Name(s)

K-FILE
HEDSTROM FILE
Reamer, Pulp Canal, Endodontic EKP Valid December 04, 2023

Device Listing

Device Name

Reamer, Pulp Canal, Endodontic

Product Code

EKP

Company Function(s)

Manufacturer

Proprietary Name(s)

Hand Reamer
All-Steel Engine Reamer
Fixture Mount Kit NYE Valid December 04, 2023

Device Listing

Device Name

Fixture Mount Kit

Product Code

NYE

Company Function(s)

Contract Manufacturer, Foreign Exporter, Manufacturer

Proprietary Name(s)

Dental Fixture Mount Kit
Universal Post Remover
Bit, Drill HTW Valid December 04, 2023

Device Listing

Device Name

Bit, Drill

Product Code

HTW

Company Function(s)

Manufacturer, Contract Manufacturer, Foreign Exporter

Proprietary Name(s)

DENTAL BURS-CONTRA ANGLE

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