Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680963

FEI Number

3000278038

Entity Name

ODONTIT SA

City/State/Country

BUENOS AIRES Buenos Aires, Ciudad Autonoma de, AR

Establishment Address

Necochea 854, BUENOS AIRES Buenos Aires, Ciudad Autonoma de 1158, AR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Foreign Private Label Distributor,Manufacture Medical Device

Owner / Operator

ODONTIT SA (Owner Number: 9012625)

Owner / Operator Contact Address

Necochea 854, --, BUENOS AIRES, AR-NOTA 1158, AR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K961631

PMA Number

N/A

All Registered Proprietary Names

ODONTIT, HEX IMPLANT, INTERNAL HEX, SQUARE, MONOBLOCK, BALL, EFEDEA, SWISS IMPLANT, SMARTGRIP, OSSEOMATE, ORTHOSOURCE Synergy Kalos Biomedical CevOss CITAGENIX Osseo Seal ODONTIT, HEX IMPLANT, INTERNAL HEX, SQUARE, MONOBLOCK, BALL, EFEDEA, SWISS IMPLANT, SMARTGRIP, OSSEOMATE, ORTHOSOURCE Kalos Biomedical

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2003-04-14
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2014-05-30
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2010-11-18

Official Correspondent

MARIO GERSBERG

US Agent Details

LLOYD R. TAYLOR Business: ORTHOSURCE, INC. Email: info@synergybiomedical.eu Phone: (818) 9829445

Related Public Records

Same Entity

ODONTIT 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
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07
K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH
Z-0024-04	Vital Concepts, Inc.	1	Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge. Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.

Similar Registrations

Registration Number	Establishment Name	Location
3017101761	IC SURGICAL INC	Grand Rapids, MI, US
3010198939	TIANJIN VANFORM HIGH ENERGY PHYSICS TECHNOLOGY CO., LTD.	Tianjin, CN
3013025177	Phillips-Medisize Healthcare (Suzhou) CO., LTD	Suzhou Jiangsu, CN
1416980	BAXTER HEALTHCARE CORPORATION	ROUND LAKE, IL, US
3026986849	FANSHENG TECHNOLOGY (GUANGDONG) CO., LTD .	Zhongshan City Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680963. Last updated year: 2026. Please use registration number 9680963 when referencing this establishment in official correspondence.