Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8030958

FEI Number

1000225541

Entity Name

INTENSIV SA

City/State/Country

Collina d'Oro / Montagnola Ticino, CH

Establishment Address

Via al Molino 107, Collina d'Oro / Montagnola Ticino 6926, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Intensiv SA (Owner Number: 9001345)

Owner / Operator Contact Address

Via al Molino 107, Collina d'Oro / Montagnola, CH-NOTA 6926, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Intensiv UniglossPaste Intensiv Proxoshape Intensiv ApproxOpener Intensiv Ortho-Strips Opener Intensiv Proxoshape Flexible Intensiv Proxoshape Coarse Intensiv Bevelshape Intensiv ProxoStrip Intensiv ProxoStrip Anterior Intensiv Ortho-Strips One-Sided Intensiv Ortho-Strips Set Intensiv Ortho-Strips Coarse Intensiv ProxoCoutour Coarse Intensiv ProxoPolish Intensiv Rootshape Intensiv Ortho-Strips Intensiv Ortho-Strips System Central Intensiv Metal Diamond Strips Intensiv Ortho-Strips System IPR-DC010/3 IPR-DC015/3 IPR-DC Set IPR-DC050/3 IPR-DC030/3 IPR-DC040/3 IPR-DC025/3 IPR-DC020/3 IPR-DC100/3 Intensiv Diamond Instruments FG and RA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2009-05-08
EHM	Strip, Polishing Agent	Dental	Class 1	872.6010	2009-05-08
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2018-03-09
DZP	Instrument, Diamond, Dental	Dental	Class 1	872.4535	1996-12-16

Official Correspondent

No official correspondent registered.

US Agent Details

DAVID LENNARZ Business: REGISTRAR CORP Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Intensiv SA

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

Similar Registrations

Registration Number	Establishment Name	Location
3010864832	3D DENTAL DESINGS AND DEVELOPMENT	Shaker Heights, OH, US
9613375	COLTENE/WHALEDENT AG	ALTSTAETTEN Sankt Gallen, CH
9616065	MANUFACTURERA DENTAL CONTINENTAL	ZAPOPAN Jalisco, MX
3004096429	E.M.S. ELECTRO MEDICAL SYSTEMS S.A.	NYON Vaud, CH
3007210751	DENTSCARE LTDA	Joinville Santa Catarina, BR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030958. Last updated year: 2026. Please use registration number 8030958 when referencing this establishment in official correspondence.