Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010414

FEI Number

3002807929

Entity Name

PRODUITS DENTAIRES SA

City/State/Country

VEVEY (SUISSE) Vaud, CH

Establishment Address

18, RUE DES BOSQUETS, VEVEY (SUISSE) Vaud CH-1800, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PRODUITS DENTAIRES SA (Owner Number: 8010414)

Owner / Operator Contact Address

18, RUE DES BOSQUETS, --, VEVEY (SUISSE), CH-NOTA CH-1800, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Articulating paper Tofflemire Matrix retainers Universal Solder Fibrapost Lux Absorbent Paper Points Disclosing Tablets Effervescent Mouth Wash Tablets, Pink Drill-A-Post Pella Transparent Crown Forms Odus Pella Transparent Crown Forms Plastic Pipettes IrriFlex Gutta-Percha Points OdneFill Matrix bands Dental floss Dental Sticks PD MTA White Cotton Pellets Dispenser Cotton Pellets

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EFH	Paper, Articulation	Dental	Class 1	872.6140	1978-05-17
JEP	Retainer, Matrix	Dental	Class 1	872.4565	1978-05-17
ECR	Setter, Band, Orthodontic	Dental	Class 1	872.4565	1986-08-20
ELR	Post, Root Canal	Dental	Class 1	872.3810	1981-06-18
EKN	Point, Paper, Endodontic	Dental	Class 1	872.3830	1978-05-17
EFT	Cleanser, Denture, Over The Counter	Dental	Class 1	872.3520	1978-05-17
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	1978-05-17
ELZ	Crown, Preformed	Dental	Class 1	872.3330	1981-06-18
EIC	Syringe, Periodontic, Endodontic, Irrigating	Dental	Class 1	872.4565	1978-05-17
EKM	Gutta-Percha	Dental	Class 1	872.3850	1978-05-17
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2024-01-23
DYO	Band, Material, Orthodontic	Dental	Class 1	872.5410	1983-09-27
JES	Floss, Dental	Dental	Class 1	872.6390	1978-05-17
KIF	Resin, Root Canal Filling	Dental	Class 2	872.3820	2013-04-22
EFN	Cotton, Roll	Dental	Class 1	872.6050	1996-10-18

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

PRODUITS DENTAIRES 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
K831136	Almore Intl., Inc.	DOUBLE BOW TOOTH SEPARATOR	1983-06-08
K902838	Denture Dynamic'S, Inc.	DENTURE DYNAMIC'S DENTURE MAGIC	1990-09-06
K882164	Arthur Blank & Co., Inc.	FLOSS CARD	1988-06-10

Similar Registrations

Registration Number	Establishment Name	Location
3021023132	WUXI LYUSMILE IMP AND EXP CO.,LTD	WUXI Jiangsu, CN
2437780	CARGUS INT'L, INC.	CONGERS, NY, US
2183301	PATTERSON DENTAL SUPPLY, INC.	ST. PAUL, MN, US
3023339277	ANHUI JM HEALTHCARE PRODUCTS CO.,LTD.	Shouxian Anhui, CN
3014683120	JMU DENTAL, INC	Fullerton, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010414. Last updated year: 2026. Please use registration number 8010414 when referencing this establishment in official correspondence.