Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1723973

FEI Number

3001236822

Entity Name

MEDENTAL INTL.

City/State/Country

VISTA, CA, US

Establishment Address

3008 PALM HILL DR., VISTA, CA 92084, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

MEDENTAL INTL. (Owner Number: 9030403)

Owner / Operator Contact Address

3008 PALM HILL DR., --, Vista, CA 92084, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Medental Medental Medental Medental Prophy Paste

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2008-03-20
EMA	Cement, Dental	Dental	Class 2	872.3275	2012-04-15
LBH	Varnish, Cavity	Dental	Class 2	872.3260	2008-03-20
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	Class 1	872.6030	2022-09-20

Official Correspondent

Jane Mitchell

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MEDENTAL INTL.

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
K952662	Jeneric/Pentron, Inc.	COMP=FLOW	1995-08-28
K171147	Bisco, Inc.	REVEAL Bulk	2017-08-04
K770922	Espe GmbH (Us)	DENTAL RESTORATIVE IN CAPSULES	1977-06-01
K153476	Kuraray Noritake Dental, Inc.	KATANA AVENCIA Block	2016-08-23
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).

Similar Registrations

Registration Number	Establishment Name	Location
3017374693	STRATASYS LTD - Headquarter	Rehovot Central, IL
3006694515	indigodental GmbH	Pinneberg Schleswig-Holstein, DE
3012421607	MAINLINE MEDICAL DENTAL SUPPLY	North York Ontario, CA
3043226252	ZAPALIGN LLC	Fort Lauderdale, FL, US
9612352	IVOCLAR VIVADENT AG	SCHAAN, LI

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1723973. Last updated year: 2026. Please use registration number 1723973 when referencing this establishment in official correspondence.