Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613208

FEI Number

3000246713

Entity Name

TDV DENTAL LTDA

City/State/Country

POMERODE Santa Catarina, BR

Establishment Address

9944, XV DE NOVEMBRO, POMERODE Santa Catarina 89107000, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TDV DENTAL LTDA (Owner Number: 9030432)

Owner / Operator Contact Address

9944, XV DE NOVEMBRO, POMERODE, BR-SC 89107000, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PROFILAX Prophy Brushes SeptoCure SeptoContact Contact + Gold FOTOPLUS Versaplus Mandrel SeptoWheels PX SeptoPlus Mandrel POLIMAX PRAXIS POLISH POLIFIX FELT WHEELS IMPREGNATED FELT WHEELS Praxis Shine MICROCUT MANUAL MICROCUT SeptoFipo Strips SERRATED DIAMOND STRIP SeptoDiamond Strips Diamond Strip APPROXIMAL FINISHING SANDPAPER ABRASIVE STEEL STRIP DIAMOND STRIP Super-Snap Polystrips POLIGLOSS DIAMOND GLOSS SeptoDiamond Paste PROPHYLAXIS STRIP SeptoProphy Strips Prophylactic Strip ANATOMIC WEDGES INTERDENTAL WEDGES SeptoWedges TRANSLUCID WEDGES INTRAPOL CERAM Praxis Diamond FIBERGLASS OPTIMIZE DIAMOND POLISH CERAM-LAB POLISHING BRUSH DIAMOND POLISH COMPO-CLINIC METAL POLISH LAB INTRAPOL UNIVERSAL DIAMOND POLISH CERAM-CLINIC DIAMOND POLISH ONE-STEP EXTRAPOL LAB ACRYL POLISH METAL POLISH SeptoPolisher Praxis Polishers ESTHETIC PLUS SeptoCompo Shape PRAXIS SUPERFIX Praxis Mandrel SeptoDiscs Mandrel SeptoDiscs SANDPAPER DISCS Finishing and Polishing Discs Finishing and Polishing Discs Mandrel MAXVIEW

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EHK	Cup, Prophylaxis	Dental	Class 1	872.6290	2006-10-25
EIY	Instrument, Filling, Plastic, Dental	Dental	Class 1	872.4565	2006-10-25
EJQ	Wheel, Polishing Agent	Dental	Class 1	872.6010	2006-10-25
EKD	Instrument, Cutting, Operative	Dental	Class 1	872.4565	2006-10-25
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2006-10-25
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2006-10-25
ELA	Instrument, Hand, Calculus Removal	Dental	Class 1	872.4565	2008-12-18
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2006-10-25
EHL	Point, Abrasive	Dental	Class 1	872.6010	2006-10-25
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2006-10-25
EHJ	Disk, Abrasive	Dental	Class 1	872.6010	2006-10-25
EIG	Retractor, All Types	Dental	Class 1	872.4565	2008-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

JESSENIA CASTILLO Business: JESSENIA CASTILLO Email: jcastillo@septodont.com Phone: (800) 8728305

Related Public Records

Same Entity

TDV DENTAL LTDA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K121698	Dentsply International, Inc.	NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN	2012-08-06

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3012312751	DENTAL BRANDS FOR LESS	Markham Ontario, CA
3006847937	Premium Plus International Limited	Hong Kong, HK
3004130302	MICERIUM S.P.A.	AVEGNO Genova, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613208. Last updated year: 2026. Please use registration number 9613208 when referencing this establishment in official correspondence.