Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010253209

FEI Number

3010253209

Entity Name

ENTA B.V.

City/State/Country

Bergen op Zoom Noord-Brabant, NL

Establishment Address

Brouwerijbaan 10, Bergen op Zoom Noord-Brabant 4615AA, NL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ENTA B.V. (Owner Number: 10044290)

Owner / Operator Contact Address

Brouwerijbaan 10, Bergen op Zoom, NL-NOTA 4615AA, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

enta®cryl

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ELM	Denture, Plastic, Teeth	Dental	Class 2	872.3590	2014-12-12

Official Correspondent

No official correspondent registered.

US Agent Details

Chris Brown Business: Aclivi, LLC Email: acliviconsulting@gmail.com Phone: (810) 3609773

Related Public Records

Same Entity

ENTA B.V.

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
K070591	Union Dental S.A./Unidesa.Odi	REPLICA, ORTOLUX TOP, ODIPAL, ODILUX, ODIDENT, VITACRILIC, NATURE'S BEST, DENTAL ACRYLIC TEETH	2007-05-11
K915276	Nobelpharma USA, Inc.	DENTURE PLASTIC TEETH,76 ELM	1992-02-03

Similar Registrations

Registration Number	Establishment Name	Location
3016564992	DENTAC LLC	North Miami, FL, US
3042623520	ZINGO DIGITAL DENTAL LAB LLC	Mount Prospect, IL, US
3007740664	Shenzhen Jiahong Dental Technology Co., Ltd	Shenzhen Guangdong, CN
3002727993	GEBDI DENTAL PRODUCTS GMBH	Engen Baden-Wurttemberg, DE
3006059056	ARVIT DENTAL LABORATORY INC.	Southampton, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010253209. Last updated year: 2026. Please use registration number 3010253209 when referencing this establishment in official correspondence.