Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613230

FEI Number

3002808025

Entity Name

RONVIG DENTAL MFG. A/S

City/State/Country

DAUGAARD Midtjylland, DK

Establishment Address

GL. VEJLEVEJ 59, DAUGAARD Midtjylland 8721, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RONVIG DENTAL MFG. A/S (Owner Number: 9029460)

Owner / Operator Contact Address

GL. VEJLEVEJ 59, --, DAUGAARD, DK-NOTA 8721, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CALAJECT CONTA-GUARD PAROJECT AQUA-PRESS EASE-IT FLEXI-TRIX FLEXI-CLAMP COMPO-JECT COMPOSITE APPLICATOR ASPIJECT CTT CERAMIC TISSUE TRIMMER

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2017-09-26
BRW	Protector, Dental	Anesthesiology	Class 1	868.5820	2011-05-03
EGM	Injector, Jet, Mechanical-Powered	Dental	Class 2	872.4475	2009-10-28
EFS	Unit, Oral Irrigation	Dental	Class 1	872.6510	2000-07-14
EEG	Heat Source For Bleaching Teeth	Dental	Class 1	872.6475	2004-02-19
DZN	Instruments, Dental Hand	Dental	Class 1	872.4565	2010-08-30
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2001-07-20
EJI	Syringe, Cartridge	Dental	Class 2	872.6770	2007-12-12
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2000-07-14

Official Correspondent

Annette Nielsen

US Agent Details

Yasily Ogando Roa Business: Parkell Email: yogando@parkell.com Phone: (631) 3891560

Related Public Records

Same Entity

RONVIG DENTAL MFG. A/S

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
K844318	Pro Pulse, Inc.	ORAL IRRIGATION TIP	1984-11-23

Similar Registrations

Registration Number	Establishment Name	Location
1058726	RUMEX INTERNATIONAL CO.	Tampa, FL, US
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
3008242564	Septodont, Inc	Lancaster, PA, US
3012507533	Integra Canada ULC	Oakville Ontario, CA
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613230. Last updated year: 2026. Please use registration number 9613230 when referencing this establishment in official correspondence.